Complications
Minor complications
In the Italian BIB® experience of 3,252 patients the incidence of minor com-
plications was 2.1 per cent (71 patients). The intragastric balloon was
removed due to intolerance in 13 patients (0.39 per cent). These patients,
although they had been suitably informed before placement as to the appear-
ance and modalities of what was likely to occur, decided to have it removed
because they found the symptoms intolerable. Breakage of the device
occurred in 19 patients (0.58 per cent) and, except in two cases, always after
the period advised by the company (6 months). Oesophagitis diagnosed after
removal of the BIB® occurred in 39 patients (1.2 per cent), probably due to
the discontinuous use of the proton pump inhibitors (Table 8).44
The Brazilian study performed by Sallet et al. reports, among the
minor complications, reflux oesophagitis in 40/683 patients (12.4 per cent)
and symptomatic gastric stasis in 28/683 patients (8.7 per cent).25
Major complications
The overall major complication was 32/3252 (0.9 per cent)44 in 19
(0.58 per cent) patients the device became displaced in the cavity
causing a typical case of gastric obstruction which totally blocked gastric
emptying (Fig. 9).
This condition was resolved with medical treatment in three cases by
inserting a naso-gastric tube for 24–48 hours, but in 16 cases this proved
to be ineffective and removal of the BIB® was required. Another compli-
cation is gastric ulceration, very frequently experienced with the 1980s
balloons, but very rare today (due to the spherical shape, the improved
characteristics and the use of the proton pump inhibitor). This complica-
tion occurred in 0.15 per cent (five patients) (Table 9). As far as we know
82
A. Genco et al.
Table 7.
Results of the multiple treatments on 57 patients (personal series).
Pre-BIB
First BIB
Second BIB
BMI
47.6
40.4
36.7
intestinal obstruction occurred in three of the 7000 patients treated in
Italy, each case entailing surgical treatment. Gastric perforation, the most
frightening complication, occurred in five patients (0.15 per cent). Four of
the latter had already undergone surgery: three at gastric level (fundopli-
cation according to Nissen, a vertical gastroplasty complicated by fistula,
gastric banding removed because of intragastric migration) and one due to
Intragastric Balloon in the Management of Morbid Obesity Disease
83
Table 8.
BIB minor complication in 3,252 patients.
BIB intolerance
0.39%
BIB breakage
0.58%
Oesophagitis
1.2%
Figure 9.
Gastric obstruction.
prior, thoracic–abdominal trauma. In three patients this complication was
treated and solved by surgical means. Two other patients died: one during
surgery and the other during diagnostic tests.
In the Brazilian experience Sallet et al.25 also include balloon
impaction in the antrum with gastric hyperdistension among the major
complications, requiring removal of gastric content under general anaes-
thesia (two cases, 0.6 per cent). There was one case (0.3 per cent) of
spontaneous deflation of the balloon and migration into the small bowel,
causing intestinal obstruction after five months of the BIB®, treated con-
servatively for the first 24 hours without satisfactory results and
subsequently removed surgically.
Discussion and Conclusion
Our experience, and the literature illustrated here, indicate that the intra-
gastric BIB® is a totally different prothesis from that used in the 1980s
because, over a short term, it is a safe and effective device. Even though
the incidence of major complications is <1 per cent (GILB data), its use
solely for cosmetic purposes is not at the moment advisable, and because
four of the five perforations occurred in patients with previous gastric
surgery, the contraindication of this factor is absolute.
The placement and removal procedures are easy, both for gastroen-
terologists and for surgeons who perform endoscopies. Physicians
must, however, take great care to follow-up their patients very closely,
particularly in the first seven days after placement. Only an attentive
and rigorous follow-up permits the timely diagnosis and appropriate
treatment of the dangerous complications which could arise in this
first phase: gastric ischemic ulcer, with subsequent perforation (4/5
occurred during the first five days after placement, GILB data) and
dehydration.
84
A. Genco et al.
Table 9.
BIB major complication in 3,252 patients.
Gastric obstruction
0.58%
Gastric ulceration
0.15%
Gastric perforation
0.15%
Despite the adverse symptoms felt by the patient during the first
two days after placement, the incidence of ‘psychological intolerance’
and subsequent early removal is, in the Italian experience, very low
(0.39 per cent). This is certainly due to two factors: the first is the lengthy,
complete and repeated information given to the patient before treatment
and, the second, keeping the patients in hospital, where they feel definitely
more ‘protected’, for two days.
In patients suffering from morbid obesity, incapable of keeping to any
diet, and who are candidates for bariatric or other types of surgery, the
intragastric balloon is the only non-surgical procedure able to induce a
rapid and consistent weight-loss which positively affects all the obesity-
related co-morbidities and reduces the risks of surgery and anaesthesia.
The ongoing trend relating to the use of the device points to sequen-
tial treatment, i.e. before and in preparation for surgery. In this respect the
data relating to super-obese patients (BMI > 50) indicated in the study
comparing it with sleeve-gastrectomy33 is very encouraging. The effective
control of co-morbidities induced by the use of the intragastric balloon
authorizes the hypothesis of a possible role for the device as the first step
in a complex surgical treatment. If further prospective studies, involving
a greater number of patients, confirm the data obtained up to now, it is rea-
sonable to hypothesize for the future performance, for example, of the
biliopancreatic diversion with sleeve gastrectomy in one sole step, after a
six-month treatment with the intragastric balloon.
The unexpected results deriving from the evaluation of our experience
in patients with five year follow-up,26 lead us to think that the BIB® will
be able to play a important role in the prevention of super-obesity, so little
discussed even by the experts in this field. The fact that one-third of
female patients, younger than 35 years and with a BMI lower than 40, are
able to maintain, or even optimize their weight loss five years after the
treatment, should stimulate the ‘precocious’ use of the BIB® in the
prevention of super-obesity and its correlated diseases.
Use of the intragastric balloon in adolescent and paediatric patients is
another possible and important field.
To be truthful, however, there is not enough scientific evidence at the
moment to support verified affirmations. The study of 21 adolescents
reported by Sallet25 can be supplemented by that of Dr F. De Peppo’s
Intragastric Balloon in the Management of Morbid Obesity Disease
85
group at the Paediatric Hospital Bambino Gesù in Rome, where 11 children
suffering from the Prader–Willi syndrome (mean age 11 years) were given
BIB® multiple treatment, with good results.45
At the present time there is no medical cure for obesity and, despite
the numerous dietary treatments, the natural course of the disease is char-
acterized by an ongoing, sometimes unstoppable, weight gain. There are
now one billion overweight or obese persons worldwide. Only some of
these patients, however, express the desire or are able to undergo a surgi-
cal operation. In this context the intragastric balloon can play a very clear
role in interrupting the ongoing and inexorable weight gain in patients
with first degree obesity and in achieving positive control or resolution or
improving of the relevant co-morbidities.24,46 In super-obese patients,
where there are numerous co-morbidities, the weight loss obtained with
the BIB® represents, on the other hand, a chance to reduce the surgical and
anaesthesiologic complications deriving from bariatric surgery. Other
endoscopic procedures such as Endobarrier and POSE have a real poten-
tial and have been added to the armamenterium of bariatric endoscopic
procedures.47
References
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volume and respiratory rate on oxygenation and respiratory mechanics
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3. Bloostom, M., Zervos, E.E., Camps, M.A. et al. (1997). Outcome following
bariatric surgery in super versus morbidly obese patients: does weight
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4. Weiner, R., Gutberlet, H., Bockhorn, H. (1999). Preparation of extremely
obese patients for laparoscopic gastric banding by gastric balloon therapy.
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5. Angrisani, L., Furbetta, F., Doldi, S.B. et al.. (2002). Results of the Italian
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6. Pasulka, P.S., Bistrian, B.R., Benotti, P.N. et al. (1986). The risks of surgery
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8. Goustout, C., Rajan, E. (2005). Endoscopic treatments for obesity: past,
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9. Dillon, J.G., Hughes, M.K. (1992). Degradation of five polyurethane gastric
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10. Geliebter, A., Melton, P.M., Gage, D. et al. (1990). Gastric balloon to treat
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584–588.
11. Hogan, R.B., Johnston, J.H., Long, B.W. et al. (1989). A double-blind,
randomized, sham-controlled trial of the gastric bubble for obesity.
Gastrointest Endosc 35(5): 381–385.
12. Kirby, D.F., Wade, J.B., Mills, P.R. et al. (1990). A prospective assessment
of the Garren-Edwards gastric bubble and bariatric surgery in the treatment
of morbid obesity. Am Surg 56(10): 575–580.
13. Benjamin, S.B., Maher, K.A., Cattau, E.L. Jr et al. (1988). Double-blind con-
trolled trial of the Garren-Edwards gastric bubble: an adjunctive treatment
for exogenous obesity. Gastroenterology 95(3): 581–588.
14. Lindor, K.D., Hughes, R.W. Jr., Ilstrup, D.M. et al. (1987). Intragastric
balloons in comparison with standard therapy for obesity — a randomized,
double-blind trial. Mayo Clin Proc 62 (11): 992–996.
15. Benjamin, S.B. (1988). Small bowel obstruction and the Garren-Edwards
gastric bubble: an iatrogenic bezoar. Gastrointest Endosc 34(6): 463–467.
16. Ulicny, K.S., Goldberg, S.J., Harper, W.J. et al. (1988). Surgical complica-
tions of the Garren-Edwards gastric bubble. Surg Gynecol Obstet 166(6):
535–540.
17. Wahlen, C.H., Bastens B., Herve J. et al. (2001). The Bioenterics Intragastric
Balloon (BIB): how to use it. Obes Surg 11: 524–527.
18. Genco, A., Cipriano, M., Bacci, V. et al. (2006). BioEnterics Intragastric
Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover
study on weight reduction in morbidly obese patients. Int J Obes (Lond)
30(1): 129–133.
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19. Torres-Barrera, G. (2006). Gastrical electrical activity before and after
Bioenterics Intragastric Balloon (BIB) placement. Digest Dis Week 20–25 May.
20. Mion, F., Napoleon, B., Roman, S. et al. (2005). Effect of intragastric
balloon on gastric emptying and ghrelin plasma levels in non-morbid obese
patients. Obes Surg 15(4): 510–516.
21. Genco, A., Bruni, T., Doldi, S.B. et al. (2005). Bioenterics Intragastric
Balloon: the Italian experience with 2,515 patients. Obes Surg 15:
1161–1164.
22. Genco, A., Balducci, S., Bacci, V. et al. (2008) Intragastric Balloon or diet
alone? A retrospective evaluation. Obes Surg 18(8): 989–992.
23. Melissas, J., Mouzas, J., Filis, D. et al. (2006). The intragastric balloon —
smoothing the path to bariatric surgery. Obes Surg 16(7): 897–902.
24. Herve, J., Wahlen, C.H., Schaeken, A. et al. (2005). What becomes of
patients one year after the intragastric balloon has been removed? Obes Surg
15(6): 864–870.
25. Sallet, J.A., Marchesini, J.B., Paiva, D.S. et al. (2004). Brazilian multicenter
study of the intragastric balloon. Obes Surg 14: 991–998.
26. Genco, A. Bioenterics Intragastric Balloon (BIB) in morbid obesity treat-
ment: 5 years results. In press.
27. Busetto, L., Enzi, G., Inelmen, E.M. et al. (2005). Obstructive sleep apnea
syndrome in morbid obesity: effects of intragastric balloon. Chest 128(2):
618–623.
28. Busetto, L., Segato, G., De Luca, M. et al. (2004). Preoperative weight loss
by intragastric balloon in super-obese patients treated with laparoscopic
gastric banding: a case-control study. Obes Surg 14(5): 671–676.
29. Weiner, R., Gutberlet, H., Bockhorn, H. (1999). Preparation of extremely
obese patients for laparoscopic gastric banding by gastric balloon therapy.
Obes Surg 9: 261–264.
30. Busetto, L., Tregnaghi, A., De Marchi, F. et al. (2002). Liver volume and
visceral obesity in women with hepatic steatosis undergoing gastric banding.
Obes Res 10: 408–411.
31. Doldi, S.B., Micheletto, G., Perrini, M.N. et al. (2002). Treatment of morbid
obesity with intragastric balloon in association with diet. Obes Surg 12:
121–127.
32. Hodson, R., Zacharoulis, D., Goutzamani, E. et al. (2001). Management of
obesity with the new intragastric balloon. Obes Surg 11: 327–329.
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33. Genco, A., Cipriano, M., Materia, A. et al. (2010). Laparoscopic sleeve
gastrectomy versus intragastric balloon: a case control study. Surg Endosc
23(8): 1849–1853.
34. Scopinaro, N., Adami, G.F., Marinari, G.M. et al. (1998). Biliopancreatic
diversion. World J Surg 22: 936–946.
35. Van Hee Robrecht, H.G.G. (2004). Biliopancreatic diversion in the surgical
treatment of morbid obesity. Editorial update. World J Surg 28(5): 435–444.
36. Biron, S., Hould, F.S., Lebel, S. et al. (2004). Twenty years of bilio-
pancreatic diversion: what is the goal of the surgery? Obes Surg 14(2):
160–164.
37. Scopinaro, N., Gianetta, E., Adami, G.F. et al. (1996). Biliopancreatic diver-
sion for obesity at eighteen years. Surgery 119: 261–268.
38. Ren, C.J., Patterson, E., Gagner, M. (2000). Early results of laparoscopic
biliopancreatic diversion with duodenal switch: a case series of 40 patients.
Obes Surg 10: 514–523.
39. Regan, J.P., Inabnet, W.B., Gagner, M. et al. (2002). Early experience with
two-stage laparoscopic Roux-en Y Gastric bypass as an alternative in the
super-super obese patients. Obes Surg 12: 245–248.
40. Rabkin, R.A., Rabkin, J.M., Metcalf, B. et al. (2003). Laparoscopic tech-
nique for performing duodenal switch with gastric reduction. Obes Surg 13:
263–268.
41. Baltasar, A., Bou, R., Miró, J. et al. (2002). Laparoscopic biliopancreatic
diversion with duodenal switch: technique and initial experience. Obes Surg
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42. Marceau, P., Hould, F.S., Lebel, S. et al. (2001). Malabsorptive obesity
surgery. Surg Clin North Am 81(5): 1113–1127.
43. Milone, L., Strong, V., Gagner, M. et al. (2005). Laparoscopic sleeve
gastrectomy is superior to endoscopic intragastric balloon as a first stage pro-
cedure for super-obese patients (BMI > or =50). Obes Surg 15(5): 612–617.
44. Genco, A. (2006). Italian Society for Bariatric Surgery, Italian Congress on
Obesity Surgery — SICOB — Florence, September.
45. Crinò, A., Di Giorgio, G., De Peppo, F. et al. (2009). Bioenterics intragastric
balloon may represent an alternative and effective treatment for body weight
control in Prader–Willi syndrome. Obes Surg 19(5): 674–675
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46. Mathus-Vliegen, E., Tytgat, G. (2005). Intragastric balloon for treatment-
resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment
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47. Bonanomi, G., Di Caro, S., Traina, M. et al. (2006). Pilot study of
Preoperative Weight Loss in Super Morbid Obese Patients: The Additional
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90
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Chapter 4
Laparoscopic Adjustable Gastric Banding
Gianni Segato, Nadey S. Hakim, Maurizio De Luca and
Franco Favretti
Introduction
The laparoscopic application1,2 of an adjustable gastric banding, intro-
duced by Kuzmack in 1986,3 is gaining more and more in consensus as a
surgical procedure for the treatment of morbid obesity. In many countries
it is the most common bariatric surgery procedure, and it is calculated that
in the last seven years about 400,000 gastric bandings have been applied
all over the world.
According to the register of the Italian Society for Obesity Surgery
(SICOB), by December 2007, 8,000 gastric bandings had been put in
place, making this the most common bariatric procedure. The advantages
of surgery that preserves the integrity of the gastrointestinal tract and that
can be carried out by laparoscopy are obvious.
The laparoscopic approach was perfected and standardized by our
group since 1993 with the use of the Lap-Band® (INAMED Health,
USA)1,4 (Fig. 1). The standardization made it possible to reduce the rate of
complications to a minimum and to obtain stable results over time.5,6
Indications and Contraindications
Many believe that adjustable gastric banding is the first-choice surgical
procedure in the majority of morbidly obese patients.2,5,7,8 In any case, the
Body Mass Index (BMI) must be higher than 40 kg/m2 or than 35 kg/m2
91
92
G. Segato et al.
in the presence of co-morbidities. Surgery is indicated only in the failed
conservative treatment of morbidly obese patients, such as long time con-
trolled diets, physical activity programmes and behavioural alterations.
The candidate patients for this kind of procedure must be committed to
changing their dietary habits permanently and materially. The adjustable
gastric banding is contraindicated in patients with:9
•
diencephalic obesity;
•
Prader–Willi syndrome;
•
chronic gastrointestinal inflammatory diseases, gastroduodenal ulcer;
•
severe cardiopulmonary failure;
•
oesophageal/gastric varices;
•
congenital or acquired gastrointestinal atresias or stenoses;
•
pregnancy;
•
alcohol or drug addiction;
•
presence of infection, if there is a possibility of the prosthesis being
contaminated;
Figure 1.
Gastric banding with Lap-Band®.
•
inability to accept the dietary restrictions required for the procedure;
•
allergic reactions to the prosthetic materials;
•
emotional instability that might affect the procedure;
•
autoimmune diseases (lupus erythematosus, scleroderma).
Preparation for Surgery
Haematochemical tests should include a full blood count (in particular
for the identification of polycythemia), count of serum electrolytes,
glycaemia with blood glucose response curve, kidney and liver function
tests and blood coagulation tests. If the patient’s history shows evidence
of thyroid and/or adrenal gland dysfunctions, a targeted hormonal study
will also be necessary.
Moreover, routine tests should also include ECG, chest X-ray, liver
sonography, oesophago–gastro–duodenoscopy (OGD) and spirometry.
Surgical Instruments
The commonly used surgical instruments for the adjustable gastric band
(Lap-Band®) positioning by laparoscopy include:1,4
•
One Veress needle;
•
One optical trocar with five 10 mm sleeves;
•
One 0° lens and one 30° lens;
•
One Endo Retract™;
•
One Endo Dissect™;
•
One Endo Shear™;
•
Articulating dissector for gastric band application (Greenstein);
•
One Endo Babcock™;
•
Two Endo Grasp™;
•
One Endo Stitch™;
•
Silk thread 2–0;
•
(TycoTMand STORZTM equipment).
Of course, the corresponding reusable equipment can also be used.
Laparoscopic Adjustable Gastric Banding
93
Patient and Surgical Team Positioning
It is believed that the patient positioning procedures and the performance
of the surgery itself are made easier if the patient is laid flat on his/her
back on the operating table with the arms spread and legs abducted (Fig. 2).
The operating table is inclined in a 30° anti-Trendelenburg position.
Compression bandages or pneumatic equipment should be used on the
legs, which should be laid straight and comfortably on pillows, for venous
compression. The surgeons, anaesthesiologist and scrub nurses are
positioned as shown in Fig. 3.
Procedural Steps
Perigastric technique
The procedure’s key points, as defined and standardized in June 1995, are
(Fig. 4):
•
identification of the reference points for dissection (equator of the
balloon containing 25 cc of air and left diaphragmatic pillar);
•
creation of the retrogastric tunnel above the peritoneal reflection of
the lesser sac;
•
creation of a ‘virtual’ pouch;
94
G. Segato et al.
Figure 2.
Patient positioning.
•
retention sutures to avoid slippage.
The surgical technique can be schematized as follows:
Insufflation
A veress needle is inserted in the usual way in the supraumbilical area. This
creates a pneumoperitoneum with a regulated 15 mm Hg intra-abdominal
pressure.
Trocar and instruments positioning
Five trocars should be introduced in the following way:
•
One 10 mm trocar for the 30° lens, at a distance of roughly six fingers
below the sternum’s xiphoid process;
Laparoscopic Adjustable Gastric Banding
95
Figure 3.
Positioning of the surgical team.
•
One 5 mm trocar for liver retraction in the subxiphoid area;
•
One 5 mm trocar in the abdomen’s upper right quad-
rant, for the grasper, the dissector and the tool used to close the
Lap-Band®;
96
G. Segato et al.
Figure 4.
Perigastric technique.
•
One 10 mm trocar in the abdomen’s left upper left quadrant for the
electrocautery hook, the needle-holder and the grasper for the intro-
duction of the Lap-Band® and tank positioning;
•
One 5 mm trocar along the left anterior axillary line, just below the rib
margin, for the use of the Endo Babcock™, the grasper and shears.
In order to minimize damage to the abdominal wall vessels and the
intraperitoneal organs, optical trocars are usually positioned under direct
vision (Visiport System, CovidienTM).
Reference points
The anaesthesiologist should introduce a calibration tube with a balloon
on the end into the stomach, through the mouth; the balloon should be
inflated with about 25 cc of air and retracted into the oesophagus–gastric
junction. The stomach should be retracted downwards. The bulge of the
balloon makes it possible for the surgeon to decide where to place the
initial dissection.
The dissection on the lesser curvature is made along the balloon’s
equator that is marked with the electrocautery hook. Therefore, the refer-
ence point on the lesser curvature is given by the balloon’s equator, while
on the greater curvature the reference point is given by the gastrophrenic
ligament next to the left pillar of the diaphragm, or the angle of His. The
identification of these two reference points is essential for the correct
positioning of the bandage.
Lesser curvature dissection–perigastric technique
The dissection of the retrogastric tunnel starts about 2 cm below the cardia
on the lesser curvature. Through the trocar, inserted in the right
hypochondrium, the grasper is used to stretch the hepatogastric ligament
and an Endo Babcock™ stretches the gastric wall through the leftmost
trocar.
This technique stretches the peritoneum of the lesser curvature. The
dissection is made as near as possible to the gastric wall, taking care not
to damage it and to preserve the Latarjet’s nerve. Under direct vision, a
Laparoscopic Adjustable Gastric Banding
97
small narrow passage is created, clearly identifying and preserving the
stomach’s posterior wall. Tunnel dissection should have the same dimen-
sions as the bandage, or be even smaller, in order to avoid slippage of the
band.
During dissection on the gastric wall, the nasogastric tube will have
to be retracted into the oesophagus in order to avoid injury to the stomach.
Retrogastric dissection
Retrogastric dissection, which is meant to connect the two previously
identified reference points, must be carried out above the peritoneal
reflection of the lesser sac. Indeed, if the band is positioned below the
peritoneal reflection of the lesser sac, an unacceptable rate of complica-
tions ensues (stomach slippage).
Gastrophrenic ligament dissection
A grasper is used through the leftmost trocar to stretch the gastric fundus
caudad, so as to place traction on the gastrophrenic ligament. A small win-
dow is then opened in this ligament with the electrocautery hook. The
position of this window normally corresponds to the most prominent part
of the left pillar of the diaphragm, very close to the angle of His. In many
cases the angle of His and the gastrophrenic ligament are masked by the
presence of a fat pad, sometimes a big one, called Belsey’s fat pad.
The banding must be applied so as to exclude this fat tissue, lest it cre-
ates a stenosis and an upper occlusion immediately after surgery.
Therefore, this fat pad needs to be excised and partially excluded, starting
from the adhesions to the diaphragm and the gastric fundus and proceed-
ing towards the oesophagus and the angle of His. In this way a perfect
vision of the gastro-oesophageal angle is obtained.
Retrogastric tunnel
A special instrument with an articulating head is introduced into the trocar
positioned in the right hypochondrium, and positioned under direct vision
in the retrogastric tunnel. The distal part of the instrument is then bent,
98
G. Segato et al.
becoming quite visible in the dissection area of the gastrophrenic liga-
ment, in front of the left diaphragmatic pillar.
The use of the electrocautery hook can help free the distal end of the
instrument, so that it emerges in the left part of the retrogastric tunnel.
Introduction and positioning of the Lap-Band® gastric bandage
The adjustable gastric bandage (Lap-Band®) and its connecting tube are
introduced in the abdominal cavity through the trocar in the left
hypochondrium. The banding is then hooked to the articulating instrument
already present in the retrogastric tunnel and slipped around the stomach
along the dissection plane.
In order to introduce the gastric banding into the abdominal cavity,
therefore, 15 mm or 18 mm diameter trocars are unnecessary. Simply
remove the 10 mm trocar from the left hypochondrium and insert the
Band following its path.
Band locking
The surgeon checks that the band is positioned correctly, using the
calibration tube. The silicone band is locked around the sub-cardiac area.
Stabilization sutures
The anaesthesiologist extracts the calibration tube. Three to five sutures
are sewn between the stomach’s serous membrane proximally to and
distally from the band, in order to prevent it from slipping. These sutures
prevent band and/or stomach slippage and are applied in the sero-
muscular layer of the stomach just before and after the band. This
anti-slippage suture needs to start as near to the greater curvature as
possible, in order to immobilize the bandage.
If there is a gap on the lesser curvature, it must be closed by stitches
applied distally from the bandage, between the lesser curvature and the
hepatogastric ligament, paying attention not to damage the vagus nerve.
In this way a ‘virtual’ proximal gastric pouch is created.
Laparoscopic Adjustable Gastric Banding
99
Port positioning
The connection tube is retracted through the port in the left hypochon-
drium. The port is then secured to the abdominal wall fascia in the left
hypochondrium with four sutures. Thanks to this port it is possible to
adjust the diameter of the new gastric stoma formed by the bandage.
Bandage adjustment
The bandage is adjusted repeatedly after surgery, under radiological
control the first time and blindly after that. The calibre of the passage
through the new gastric stoma is regulated according to the patient’s
needs, the weight loss and the radiological images.
Pars flaccida approach
In the last few years a new method, known as the pars flaccida approach,
has been proposed for the creation of the retrogastric tunnel. This has rap-
idly gained consensus and is widely used, as it is considered easier to learn
compared to the perigastric approach, and probably less conducive to
complications (perforations and slippage); see Fig. 5.
Once the lesser omentum’s pars flaccida has been divided up to the
extragastric vagal fibres, which are preserved, the liver’s caudate lobe and
the right diaphragmatic pillar become visible. The pillar’s anterior edge,
next to the inflated intragastric balloon’s equator (see above), is marked
with the electrocautery hook. This is the starting point for the blunt
dissection towards the angle of His, remaining in front of the plane of the
diaphragmatic pillars, just as in fundoplication operations in cases of
gastroesophageal reflux disease or hiatal hernia.
During dissection the balloon should be deflated and the calibration
tube retracted inside the oesophagus, to avoid injury.
The level of this retrogastric tunnel is also high, as it is positioned
quite close to the gastro–oesophageal junction. In order to avoid accessing
the mediastinum and/or damaging the posterior gastric wall, it is advisable
to check the position of the oesophagus and of the gastric wall, with the
help of the calibration tube.
100
G. Segato et al.
Laparoscopic Adjustable Gastric Banding
101
Figure 5.
Perigastric, pars flaccida and mixed approaches.
Mixed technique
It is possible to use a combination of the two previous techniques, espe-
cially in the case of viscerally obese patients, to avoid too much tissue
being included in the bandage.
The dissection starts according to the pars flaccida approach, and
once the tunnel is created, the bandage tube can be positioned therein. At
this point, the surgeon may shift to the perigastric technique and, near the
equator of the calibration tube balloon, create an antero–posterior–-
perigastric opening along the lesser curvature until the tube, already
positioned with the pars flaccida technique, is met, grasped and pulled
through. Therefore, the bandage is positioned from the angle of His to the
perigastric window (see Fig. 5).
References
1.
Favretti, F., Cadière, G.B., Segato, G. et al. (1997). Laparoscopic adjustable
gastric banding (Lap-Band®): how to avoid complications. Obes Surg 7:
352–358.
2.
Favretti, F., Cadière, G.B., Segato, G. et al. (1998). Bariatric analysis and
reporting outcome system (BAROS) applied to laparoscopic banding
patients. Obes Surg 8: 500–504.
3.
Kuzmack, L. (1986). Gastric banding. In: Deitel M. (ed.). Surgery for the
Morbidly Obese Patient, pp. 225–259, Lea & Febbiger, Philadelphia.
4.
Favretti, F., Segato, G., Ashton, D. (2007). Laparoscopic adjustable gastric
banding in 1791 consecutive obese patients: 12-year results. Obes Surg 17:
168–175.
5.
Busetto, L., Pisent, C., Segato, G. et al. (1997). The influence of a new timing
strategy of band adjustment on the vomiting frequency and the food con-
sumption of obese women operated with laparoscopic adjustable silicone
gastric banding (LAP-BAND®). Obes Surg 7: 505–512.
6.
Busetto, L., Valente, P., Pisent, C. et al. (1996). Eating pattern in the first year
following adjustable silicone gastric banding (ASGB) for morbid obesity.
Obes Surg 20: 539–546.
7.
Belachew, M., Legrand, M., Vincent, V. et al. (1998). Laparoscopic adjustable
gastric banding. Obes Surg 22: 955–963.
102
G. Segato et al.
8.
Busetto, L., Segato, G., De Marchi, F. et al. (2002). Outcome predictors in
morbidly obese recipients of an adjustable gastric band. Obes Surg 12: 83–92.
9.
National Institutes of Health Consensus Development Conference Statement
(1991). Gastrointestinal Surgery for Severe Obesity, National Institutes of
Health, Bethesda MD, 25–27 March.
Suggested Reading
Cadière, G.B., Bruyns, J., Himpens, J. et al. (1994). Laparoscopic gastroplasty for
morbid obesity. Br J Surg 81: 1524–1525.
Cadière, G.B., Favretti, F., Bruyns, J. et al. (1994). Gastroplastie par coeliovideo-
scopie: Technique. Le Journal de Celio-Chirurgie 10: 27–41.
Chevallier, J.M., Zinzindohoue, F., Elian, N. et al. (2002). Adjustable gastric
banding in a public university hospital: prospective analysis of 400 patients.
Obes Surg 12: 93–99.
De Jong, I.C., Tan, K.G., Oostenbroek, R.J. (2000). Adjustable silicone gastric
banding: a series with three cases of band erosion. Obes Surg 10: 26–32.
Dixon, J.B., Dixon, M.E., O’Brien, P.E. (2001). Pre-operative predictors of
weight loss at 1-year after Lap-Band®surgery. Obes Surg 11: 200–207.
Fabry, H., Van Hee, R., Hendrickx, L. et al. (2002). A technique for prevention of
port complications after laparoscopic adjustable silicone gastric banding.
Obes Surg 12: 285–288.
Meir, E., Van Baden, M. (1998). Adjustable silicone gastric banding (ASGB) and
band erosion (BE). Obes Surg 8: 385.
Meir, E., Van Baden, M. (1999). Adjustable silicone gastric banding and band
erosion: personal experience and hypotheses. Obes Surg 9: 191–193.
Susmallian, S., Ezri, T., Charuzi, I. (2002). Laparoscopic repair of access port site
hernia after LAP-BAND®system implantation. Obes Surg 12: 682–684.
Laparoscopic Adjustable Gastric Banding
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Chapter 5
Long-Term Results in Laparoscopic
Adjustable Gastric Banding (LAP-BAND®)
for Obese Patients
Maurizio De Luca, Luca Busetto, Gianni Segato,
Nadey S. Hakim and Franco Favretti
Introduction
A bariatric operation is currently the only effective treatment for morbid
obesity in terms of inducing and maintaining satisfactory weight loss and
decreasing weight-related co-morbidities. Laparoscopic access for
bariatric operation has had a profoundly positive impact in terms of
reducing recovery time and perioperative complications. Although
laparoscopic Roux-en-Y gastric bypass (RYGB) is considered the gold
standard in the United States, most European surgeons prefer a less
invasive, reversible procedure, such as laparoscopic adjustable gastric
banding (LAGB).
LAGB is the most commonly performed surgical procedure for mor-
bid obesity in Europe, Australia and South America. To date, more than
300,000 of these bariatric procedures have been performed worldwide.
LAGB has gained in popularity around the world as a first-choice surgi-
cal therapy for severely obese patients.1
LAGB is a purely restrictive operation that relies on decreased
amount of intake as the mechanism for weight loss, and has less risk of
malnutrition than with diversionary or bypass procedures. Adjustable gas-
tric banding involves the surgical implantation of an inflatable silicone
105
106
M. De Luca et al.
band around the uppermost part of the stomach, which is tightened
according to individual weight loss and appetite.
Band tightening or adjustments are performed by percutaneously by
accessing a subcutaneous reservoir port that is connected to the band, and
injecting fluid into the system.
True judgment of any bariatric procedure requires sound data, not
only with regard to the surgical technique and its related mortality, mor-
bidity and weight loss, but also to the procedure’s impact on baseline
co-morbidities and life expectancy.
Such data can be provided only by studies that have a very high
follow-up rate extended over the long-term. Short- and medium-term
series have found the band to be both safe and effective. However, a
paucity of large long-term follow-up studies has created uncertainty in
some about the efficacy over time.
Laparoscopic Technique
Perigastric dissection
The key steps of the laparoscopic procedure, defined and standardized by
our team2 and by the Free University of Brussels in June 1995, are:
1)
establishment of reference points for dissection (equator of the bal-
loon inflated with 25 cc of air at the left crus);
2)
creation of a retrogastric tunnel above the peritoneal reflection of the
bursa omentalis;
3)
creation of a ‘virtual’ pouch;
4)
embedding of the band.
The main steps of the procedure we use, known as the ‘perigastric
technique’, are summarized below.
After initiation of pneumoperitoneum, four 5mm and one 10mm
ports are created. They are located at the junction of the upper third and
second third of the xipho-umbilical line (5mm), below the xiphoid (5mm),
in the left (10mm) and right hypochondrium (5mm) and on the left ante-
rior axillary line below the rib cage (5mm). All the ports are introduced
by means of an optical port (VisiportTM) or screw port (EndoTipTM) in
order to reduce the risk of damaging abdominal organs and abdominal
wall vessels.
A calibrated balloon-tipped orogastric tube is inserted into the stom-
ach. The balloon is inflated with 25ml of air and withdrawn to the
gastro-oesophageal (GO) junction. This allows clear visibility along the
lesser curve and into the phreno-gastric ligament. These two sites corre-
spond to the most bulging part of the balloon and are marked with the
coagulating hook. The reference point on the lesser curvature is the equa-
tor of the balloon, which, on the phreno-gastric ligament on the greater
curvature, corresponds to the left crus. The identification of these two
points is essential to ensure correct positioning of the band. The left crus
is dissected.
To avoid gastric wall injuries, the calibration tube must be withdrawn
during dissection, which must be done perpendicularly so as not to enter
the inferior mediastinum along the oesophagus.
A tunnel is created behind the stomach, joining the two dissected ref-
erence points. The bursa omentalis (lesser sac) should not be entered, and
the dissection should be performed in the phreno-gastric ligament above
the peritoneal reflection of the bursa omentalis. An articulating dissector
(or equivalent instrument) is passed through the tunnel to grasp the tip of
the band. The band is introduced through the path of the left subcostal
port. The 10mm port is removed, and its path is utilized. However, the
manufacturer recommends that the band be passed into the abdominal
cavity via a 15mm or 18mm trocar.
The calibration tube provided with the band is used to check the cor-
rect placement of the band prior to locking it. The inflatable balloon of the
calibration tube is inflated to 15–25ml and the tube is pulled up against
the bottom of the GO junction. The band should be positioned over the
bulge created by the balloon from the middle of the balloon on the lesser
curve, to the top of the balloon at the angle of His. Gastric tissue should
be clearly seen above the band. A ‘virtual’ pouch based on the 25ml ini-
tial measurement is created. A loose fit can be evaluated by deflating the
balloon and nearly locking the band over the calibration tube. There
should be room for an instrument to pass bluntly under the band. If the
band appears to be too tight, then loosen the band to allow for access to
Long-Term Results in Laparoscopic Adjustable Gastric Banding
107
remove or incise excess omental tissue. Blunt dissection is recommended
to avoid damaging the gastric wall. Re-check the ‘fit’ before proceeding.
The band is then locked in place over the calibration tube, with a final
confirmation of adequate space under the band. The band is left either
empty or only slightly inflated to avoid post-operative obstruction. Next,
retention sutures are applied to prevent band slippage and/or stomach slip-
page; these anti-slippage sutures are placed in the seromuscular layer of
the stomach from proximal to distal to the band and should start as close
as possible to the greater curvature, embedding the band. If there is a gap
on the lesser curvature, it should be closed by applying one or two stitches
distal to the band from the lesser curvature to the hepato-gastric ligament,
taking care not to damage the vagus nerve. The reservoir (access port) is
implanted on the left anterior rectus sheath just distal to the costal margin.
Pars flaccida dissection
As one of the first centres to utilize the LAP-BAND® System, proficiency
was gained with the peri-gastric dissection technique. We continue to uti-
lize this approach satisfactorily. However, in recent years there has been a
shift in training towards a slightly different dissection path around the
stomach, now known as the pars flaccida technique.3 This approach is
readily understood and adopted by new LAP-BAND® surgeons due to the
similarities to the common approach for a Nissen fundoplication. It has
also been reported to be associated with a reduced operative incidence of
gastric perforation as well as post-operative incidence of erosion and slip-
page. Briefly, this dissection begins directly lateral to the equator of the
calibration balloon in the avascular space of the pars flaccida. Once the
caudate lobe of the liver is visible, blunt dissection is continued over to
the angle of His (after the right crus, and then the left crus have been sighted).
Pars flaccida to perigastric dissection
Some surgeons use a combination of both of the above methods of dis-
section of the lesser curvature, called the pars flaccida to perigastric
technique.4 This dissection is made at the mid-point (equator) of the
balloon near the stomach until the perigastric dissection intercepts the
108
M. De Luca et al.
pars flaccida dissection. This second window does not require comple-
tion of the entire perigastric dissection. Creation of a simple path next to
the lesser curve is required to ‘pick up’ the band tubing lying in the pars
flaccida path. The band is then placed from the angle of His through to
the perigastric opening. This method is especially valuable in very large
men who may have excessive intra-abdominal adipose tissue which can
result in the band being too tight in the early post operative period.
Moving to the perigastric location brings the band closer to the stomach
and avoids including the thick lesser omentum within the band in these
patients.
Role of the Balloon
The rate of intraoperative complications is higher in the super-obese than
in morbidly obese patients. In laparoscopic surgery, the creation and
maintenance of the pneumoperitoneum is particularly worrisome in super-
obese patients, and the operative field is frequently poorly visualized with
a high rate of conversion to open surgery.
The BioEnterics® Intragastric Balloon System (BIB®) has been found
to improve the conditions for laparoscopic surgery, reducing the rate of
conversion to open surgery and the rate of intraoperative complications in
super-obese patients during LAGB. Both the placement and the removal
of the BIB® device are performed under deep sedation with anaesthesio-
logical assistance. Under endoscopic control, the deflated balloon should
be introduced through the mouth and positioned in the stomach cavity.
The balloon should then be injected with 500–700 ml of saline and meth-
ylene blue (50:1). A modified liquid diet should be followed for the first
two weeks. Continuous treatment with a proton pump inhibitor is recom-
mended while the balloon is in place. Balloon removal can take place on
an outpatient basis six months after placement. Under endoscopic control,
the balloon is punctured with a sclerosis needle, deflated, grabbed and
gradually extracted. In general, we suggest that the LAP-BAND® can be
placed one month after the balloon removal.
The preoperative weight loss produced by the BIB® is associated with
a reduced rate of conversion to open surgery and of intraoperative
complications.5 Operative time and hospital stay are also significantly
Long-Term Results in Laparoscopic Adjustable Gastric Banding
109
shortened. It has been observed that in the first phase of weight loss
following LAP-BAND® placement, a preferential reduction of visceral fat
and a 12 per cent reduction of liver volume occurs. It is possible that sim-
ilar variations in intra-abdominal anatomy can explain the positive impact
of the preoperative weight loss on laparoscopic surgery provided by the
intragastric balloon. It is obvious that these changes are related to the
weight loss and not to the use of the BIB® per se. However, the weight
loss obtained by the BIB® has been found to be higher than the weight loss
obtained by diet only.
However, in a published study of our group, no significant differences
between the two groups were observed at the following postoperative
evaluations.5 The weight loss attained by the two groups is very similar
starting from one year after banding. Preoperative treatment with the
intragastric balloon should not therefore be viewed as means to improve
the long-term results of gastric banding.
Perioperative weight loss to reduce the surgical risk in these can-
didates for bariatric surgery is an established indication for use of the
balloon. This sequential therapy should be considered in patients with
extreme obesity.
Lap-Band® Series at Vicenza Regional Hospital, Padua
Methods
Our total series consists of 2,245 patients (September 1993–December
2007). We analysed a subset of 1,791 patients with a follow-up rate of
91 per cent.
From September 1993 through December 2005 1,791 consecutive
patients underwent gastric banding surgery for morbid obesity at our insti-
tutions (Obesity Centres of Vicenza Regional Hospital and Padova
University). All operations were performed by the same team of surgeons
utilizing the LAP-BAND® Adjustable Gastric Banding System and all
patients met the eligibility criteria for bariatric surgery according to the
NIH Consensus Conference Statement of 1991.6
Outcomes measured over 12 years included mortality, complications,
weight loss and resolution/improvement of co-morbidities. Life expectancy
was evaluated in an adjunct study of LAP-BAND® versus medical therapy.
110
M. De Luca et al.
Preoperatively-recorded characteristics of 1,345 female (75.1 per cent)
and 446 male (24.9 per cent) patients were: mean age 38.7 ± 10.9 years,
mean height 1.66 ± 0.09 metres, mean weight 127.7 ± 24.3 kg, and mean
BMI 46.2 ± 7.7.
Baseline co-morbidities were present in 71 per cent of our patients:
57.8 per cent suffered from osteoarthritis, 35.6 per cent hypertension, 31.4
per cent Obstructive Sleep Apnoea Syndrome (OSAS), 27.1 per cent dys-
lipidemia, 22.0 per cent type II diabetes, 21.2 per cent depression, 9.3 per
cent hyperuricaemia, 8.7 per cent gallstones, 4.9 per cent amenorrhea, and
1.4 per cent heart failure.
Of 1,791 patients, 125 (7 per cent) underwent preoperative applica-
tion of a BIB® (Bioenterics Intragastric Balloon) with the aim of reducing
the surgical risk. Their mean age was 44.8 ± 11.8 years, mean height 1.68 ±
0.10 metres, mean weight 161.4 ± 30.1 kg and mean BMI 56.8 ± 9.1.
The perigastric dissection, as has been previously described,2 was
performed in 1,393 patients (77.8 per cent), the pars flaccida technique
was used in 384 (21.5 per cent) and the combined approach in 14 (0.8 per
cent). Table 1 shows the number of operations performed per year.
Long-Term Results in Laparoscopic Adjustable Gastric Banding
111
Table 1.
Number of operations per year follow-up rate (mean follow-up 91 per cent).
No. of
Follow-up
N. pts
Follow-up
Year
operations
Total
years
follow-up
rate (per cent)
1993
4
4
12
4
100
1994
18
22
11
22
100
1995
59
81
10
74
91.3
1996
129
210
9
188
89.5
1997
130
340
8
311
91.4
1998
143
483
7
415
85.9
1999
168
651
6
588
90.3
2000
192
843
5
765
90.7
2001
133
976
4
895
91.7
2002
143
1119
3
1001
89.4
2003
201
1320
2
1198
90.7
2004
198
1518
1
1353
89.1
2005
273
1791
—
—
—
Patients were followed at 1, 3, 6 and 12 months post-operatively and
yearly thereafter. All data concerning mortality, complications, reoperations,
weight loss and co-morbidities were recorded during the follow-up visits.
Band adjustments were performed with barium swallow under
fluoroscopy.
The co-morbidities were specifically investigated in 830 consecutive
patients, consisting of 647 women (77.9 per cent) and 183 men (22.1 per
cent), from September 1993 until November 2005.7 For this group of
patients a complete cardiovascular risk factor profile was collected both
before and 12–18 months after surgery (mean follow-up time: 15.3 ± 2.1
months).
Results
There was zero surgical mortality in our entire series of 1,791 patients.
The follow-up rate at 12 years was 91 per cent.
The conversion rate was 1.7 of which 1.2 per cent was due to techni-
cal problems such as difficult perigastric dissection and giant left liver
lobe hypertrophy, 0.5 per cent caused by intraoperative complications
such gastric perforation and bleeding.
The 125/1,791 patients who had a BIB® applied preoperatively lost
24.7 ± 11.7 kg, 8.7 points of BMI and a percentage EWL of 27.9 ± 11.8
at the time of LAP-BAND® placement.
This group of patients showed the same conversion and intraoperative
complication rate as the rest of the series.
Major complications requiring reoperation occurred in 106 patients
(5.9 per cent); see Table 2.
These included:
•
Stomach slippage and pouch dilatation in 70 patients (3.9 per cent).
The bands were removed in 20 patients (1.1 per cent) and repositioned
in 50 patients (2.8 per cent).
•
Erosion in 16 patients (0.9 per cent). The bands were removed.
•
Psychological intolerance in 14 patients (0.7 per cent). The bands
were removed.
112
M. De Luca et al.
•
Miscellaneous (HIV, infection, microperforation) in five patients
(0.27 per cent), whose bands were removed); gastric necrosis in one
patient (0.05 per cent); a gastrectomy was performed.
If we exclude the 31 major complications of the learning curve period (the
first 100 patients), the complication rate is reduced to 4.4 per cent.
Of the 41 patients (2.3 per cent) with unsatisfactory results, the band
was removed in 12 (0.7 per cent). A classical biliopancreatic diversion
was performed in 5 (0.27 per cent) and a biliopancreatic diversion with
gastric preservation (‘bandinaro’) was done in 24 (1.3 per cent) (see
Table 2).
Minor complications requiring reoperation occurred at the port site in
200 patients (11.2 per cent). The port was substituted in 182 (10.2 per
cent), repositioned in 9 (0.5 per cent) and removed in 9 (0.5 per cent).
(These port issues, almost entirely related to the port-tubing transition,
Long-Term Results in Laparoscopic Adjustable Gastric Banding
113
Table 2.
Major complications requiring reoperation (106/1,791 patients, September
1993 – December 2005).
Rate of
Rate of
complications
reoperation
Complications
Number
(per cent)
Reoperation
Number
(per cent)
Stomach slippage +
70
3.9
• Removal
20
1.1
pouch dilatation
• Repositioning
50
2.8
Erosion
16
0.9
Removal
16
0.9
Psychological
14
0.7
Removal
14
0.7
intolerance
Miscellaneous
5
0.27
Removal
5
0.27
(HIV, infections,
microperforation)
Gastric necrosis
1
0.05
Gastrectomy
1
0.05
Total
106
5.9
Total
106
5.9
Unsatisfactory
41
2.3
• BPD
5
0.27
results
• Removal
12
0.7
(lack of
• “BandInaro”
24
1.3
compliance)
were more common early in our experience. With refinements to the
placement technique and design improvements to the port tubing, these
complications have been all but eliminated.)
Weight loss (kg, BMI, percentage EWL) for the entire series is repre-
sented in Table 3 and shown in Figs. 1–4. At ten years the average weight
was 101.4 ± 27.1 kg (loss of 26.3 kg), the BMI 37.7 ± 9.1 (loss of 8.5
points) and the percentage EWL was 38.5 ± 27.9.
114
M. De Luca et al.
0
20
40
60
80
100
120
140
160
180
200
0
1 y
2 y
3 y
4 y
5 y
6 y
7 y
8 y
9 y
10 y 11 y 12 y
Kg
1791
1518
1320
4
22
81
210
340
483
651
843
976
1119
Figure 1.
Weight loss (kg) of the entire series.
Table 3.
Weight loss (kg, BMI, %EWL) of the entire series.
Time
Weight
BMI
%EWL
0
127.7 ± 24.3
46.2 ± 7.7
—
1 y
103.7 ± 21.6
37.7 ± 7.1
40.3 ± 19.7
2 y
101.5 ± 23.3
36.8 ± 7.6
43.7 ± 21.7
3 y
102.5 ± 22.5
37.2 ± 7.2
41.2 ± 23.2
4 y
104.1 ± 23.5
37.8 ± 7.5
38.6 ± 24.4
5 y
105.0 ± 23.6
38.1 ± 7.6
37.3 ± 25.3
6 y
105.3 ± 24.6
38.1 ± 8.1
37.4 ± 28.2
7 y
106.8 ± 24.3
38.5 ± 7.9
35.9 ± 26.7
8 y
105.0 ± 24.0
37.8 ± 7.9
37.7 ± 26.7
9 y
103.3 ± 26.2
37.5 ± 8.5
38.5 ± 27.9
10 y
101.4 ± 27.1
37.7 ± 9.1
35.4 ± 29.6
11 y
101.2 ± 31.9
38.1 ± 11.5
38.4 ± 32.8
12 y
84.0 ± 27.5
31.6 ± 8.5
49.2 ± 49.5
Long-Term Results in Laparoscopic Adjustable Gastric Banding
115
0
10
20
30
40
50
60
70
BMI
1791
1518
1320
1119
976
843
651
483
340
210
81
22
4
0
1y
2y
3y
4y
5y
6y
7y
8y
9y
10y 11y 12y
B
Figure 2.
Weight loss (BMI) of the entire series.
0
1y
2y
3y
4y
5y
6y
7y
8y
9y
10y 11y 12y
0
10
20
30
40
50
60
70
% EWL
1791
1518
1320
1119
976
843
651
483
340
210
81
22
4
Figure 3.
Weight loss (% EWL) of the entire series.
Figure 4.
Weight loss (kg) in super and morbid obese patients.
0
20
40
60
80
100
120
140
160
180
0y
1y
2y
3y
4y
5y
6y
7y
8y
9y 10y 11y 12y
Super
Morbid
Kg
K
1307
976
819
690
612
523
381
269
197
125
48
12
3
484
374
317
274
242
204
151
113
70
41
15
3
Results for the morbidly obese (BMI ≤49) and super-obese (BMI ≥50)
were separated into two groups for evaluation/comparison and weight loss
in terms of kg and BMI is reported in Table 4 and shown in Fig. 5. At ten
years the weight of the morbidly obese group was 94.6 ± 18.0 kg and was
116
M. De Luca et al.
Table 4.
Weight loss (kg, BMI) in super and morbidly obese patients.
n.
Weight
BMI
Time
Morbid
Super
Morbid
Super
Morbid
Super
0 y
1307
484
118.4 ± 16.9
152.8 ± 23.7***
42.6 ± 4.3
56.2 ± 5.8***
1 y
976
374
96.6 ± 16.3
122.1 ± 22.9***
34.8 ± 4.7
45.0 ± 7.0***
2 y
819
317
95.3 ± 20.2
117.4 ± 23.4***
34.3 ± 6.2
43.3 ± 7.3***
3 y
690
274
96.4 ± 18.1
118.0 ± 24.8***
34.7 ± 5.2
43.5 ± 7.7***
4 y
612
242
97.7 ± 18.7
120.3 ± 26.6***
35.2 ± 5.4
44.3 ± 8.1***
5 y
523
204
98.6 ± 18.9
121.3 ± 26.6***
35.6 ± 5.5
44.6 ± 8.4***
6 y
381
151
98.6 ± 19.4
122.3 ± 28.0***
35.4 ± 5.8
44.9 ± 9.1***
7 y
269
113
100.5 ± 19.8
121.8 ± 27.4***
35.8 ± 5.7
44.8 ± 8.7***
8 y
197
70
99.0 ± 19.1
122.0 ± 28.1***
35.4 ± 5.6
44.5 ± 9.4***
9 y
125
41
96.7 ± 18.2
123.6 ± 35.2***
35.0 ± 5.4
44.9 ± 13.9***
10 y
48
15
94.6 ± 18.0
123.2 ± 38.5**
35.2 ± 5.4
45.7 ± 13.5***
11 y
12
3
92.1 ± 20.3
137.7 ± 48.9*
34.4 ± 6.6
53.0 ± 16.2**
12 y
3
0
84.0 ± 27.5
—
31.6 ± 8.5
—
Student’s t-test: * = p < 0.05; ** = p < 0.01; *** = p < 0.001.
0
10
20
30
40
50
60
70
0y
1y
2y
3y
4y
5y
6y
7y
8y
9y 10y 11y 12y
Super
Morbid
BMI
1307
976
819
690
612
523
381
269
197
125
48
12
3
484
374
317
274
242
204
151
113
70
41
15
3
Figure 5.
Weight loss (BMI) in super and morbid obese patients.
123.2 ± 38.5 kg in the super-obese group, indicating weight losses of 23.8
kg and 29.6 kg, respectively.
At ten years the BMI in the morbidly obese group was 35.2 ± 5.4 and
44.9 ± 13.9 in the super-obese group, down 7.4 and 11.3 points, respectively.
The percentage EWL in the morbidly and super-obese groups is
reported in Table 5 and shown in Fig. 6. At ten years, percentage EWL
was 40.3 ± 27.6 and 36.0 ± 30.2, respectively.
The effect of LAP-BAND® was specifically analysed in our first 830
consecutive patients.7 The prevalence of diabetes at baseline was 11.2 per
cent (17.7 per cent in men and 9.2 per cent in women; p < 0.05); 36.2 per
cent of the patients with diabetes were treated with oral hypoglycaemic
drugs and none with insulin. Hypercholesterolaemia was diagnosed in
53.9 per cent of patients (48.4 per cent in men and 55.4 per cent in
women), low HDL-cholesterol in 13.1 per cent (18.8 per cent in men and
11.5 per cent in women) and hypertriglyceridaemia in 19.4 per cent (30.6
per cent in men and 16.0 per cent in women; p < 0.01 per cent). Finally,
the prevalence of hypertension was 32.2 per cent (45.9 per cent in men
Long-Term Results in Laparoscopic Adjustable Gastric Banding
117
Table 5.
Weight loss (% EWL) in super and morbidly obese patients.
n.
Weight loss
% EWL
Time
Morbid
Super
Morbid
Super
Morbid
Super
0 y
1307
484
—
—
—
—
1 y
976
374
21.7 ± 11.2
30.9 ± 15.6***
42.3 ± 20.4
35.1 ± 16.6***
2 y
819
317
23.2 ± 15.5
34.4 ± 16.9***
45.2 ± 25.5
39.8 ± 18.5**
3 y
690
274
21.8 ± 13.4
33.7 ± 18.0***
42.1 ± 20.4
39.1 ± 19.5*
4 y
612
242
20.5 ± 13.5
31.0 ± 19.2***
39.6 ± 25.5
36.2 ± 21.0*
5 y
523
204
19.8 ± 13.8
30.1 ± 19.6***
38.1 ± 26.5
35.1 ± 21.7
6 y
381
151
20.1 ± 15.1
29.1 ± 21.5***
38.7 ± 29.7
33.9 ± 23.9*
7 y
269
113
18.7 ± 13.5
29.0 ± 20.4***
36.6 ± 27.8
34.0 ± 23.9
8 y
197
70
19.9 ± 13.9
28.7 ± 20.5**
38.8 ± 27.2
34.5 ± 24.9
9 y
125
41
20.2 ± 13.9
26.1 ± 22.4
40.3 ± 27.6
32.9 ± 28.7
10 y
48
15
17.6 ± 14.2
29.2 ± 22.7
35.2 ± 29.7
36.0 ± 30.2
11 y
12
3
20.5 ± 18.6
25.7 ± 5.1
40.9 ± 36.1
28.3 ± 13.3
12 y
3
0
16.5 ± 14.6
—
49.2 ± 49.5
—
Student’s t-test: * = p < 0.05; ** = p < 0.01; *** = p < 0.001.
and 27.9 per cent in women; p < 0.001), with 60.6 per cent of hypertensive
patients being treated pharmacologically.
Discussion
The conversion rate is 0.1–1.7 per cent which in most cases is due to tech-
nical problems such as difficult perigastric dissection and giant left liver
lobe hypertrophy.
Of the major complications requiring reoperation (5.9 per cent), stom-
ach slippage with pouch dilatation accounts for 2.3–3.9 per cent.8–10
One of the most appealing aspects of gastric banding is its total
reversibility, which is important in cases of psychological intolerance of
the prosthesis. In case of unsatisfactory results, due mainly to the patient’s
lack of compliance, a biliopancreatic diversion with gastric preservation
can be offered.11
There is a 0.1 per cent of patients who require reoperation due to intra-
abdominal haemorrhage from a trocar site, the same values discussed in
any advanced laparoscopic surgery.
Minor complications requiring reoperation include those occurring at
the port-site with an approximate occurrence of 11.2 per cent. In most
cases, a leak can be detected and the port substitution required. In a minor-
ity of patients, the port has to be repositioned for pain (0.5 per cent) or
118
M. De Luca et al.
0
10
20
30
40
50
60
0y
1y
2y
3y
4y
5y
6y
7y
8y
9y 10y 11y 12y
Super
Morbid
% EWL
1307
976
819
690
612
523
381
269
197
125
48
12
3
484
374
317
274
242
204
151
113
70
41
15
3
Figure 6.
Weight loss (BMI) in super and morbid obese patients.
removed because of infection (0.5 per cent). With the use of ‘low-profile’
ports the leakage rate has been greatly reduced.12,13
A mortality rate of 0 per cent in all major studies attests to the benign
nature of the surgery.14,15 The Australian Safety and Efficacy Register of
New Interventional Procedures–Surgical systematic review of the world-
wide literature found a significant difference in mortality between the
RYGB, vertical banded gastroplasty and LAGB. The LAGB had one
death in 2,000 (0.05 per cent), which is one-tenth the mortality seen with
RYGB and one-sixth the mortality with vertical banded gastroplasty. In a
study from a New York University programme, the LAGB had signifi-
cantly fewer complications compared with RYGB and biliopancreatic
diversion with duodenal switch (10 per cent versus 29.2 per cent versus
27.6 per cent).16
With regard to the weight loss curves, in the long term the average
weight is expected to decrease an average of 26.3 kg with a decrease of
8.5 of BMI score. The curves are stable over time, with no statistically
detectable rebound. Weight loss associated with the LAGB is slower com-
pared with that seen with RYGB, progression is gradual over a two to four
year period and then usually stabilizes at approximately 50–60 per cent,
corresponding with that of RYGB in the same time frame.14
There was a difference in the results of the morbidly obese patients
(BMI < 50) and super-obese patients (BMI > 50) with better results in
the super-obese patients. After the fourth year no statistical difference
between the value of the two curves has been proved and they tend to
merge together. The weight loss that can be observed in morbidly obese
patients in the first 12–18 months after gastric banding is associated
with clinically significant improvements in multiple cardiovascular risk
factors.17
However, only a low level of correlation can be observed between
the degree of body weight reduction and the magnitude of cardiovascu-
lar risk improvement. In particular, a 10–11 per cent weight loss appeared
to be associated with the maximal benefit in diabetic control, with no fur-
ther gain being derived from more pronounced levels of body weight
reduction.18,19
O’Brien et al. observed that after LAGB, patients experienced 74 per
cent improvement or resolution of dyslipidemia, 94 per cent resolution of
Long-Term Results in Laparoscopic Adjustable Gastric Banding
119
obstructive sleep apnoea, 55 per cent resolution of hypertension, 100 per
cent improvement of asthma, and 76 per cent resolution with 14 per cent
improvement in gastro-oesophageal reflux. Weight loss following LAGB
surgery has a major impact on type II diabetes mellitus, with resolution or
improvement of diabetes in 80.8 per cent of patients.7,14,19
Life Expectancy Study
Working with epidemiologists and internists of the Multisites Cohort of
the Italian Study Group on Morbid Obesity, our group was able to conduct
a case/control study on the effect of the LAP-BAND® on life expectancy
(see also Chapters 12 and 13).17,20
In this study 821/1,791 of our LAP-BAND® patients were matched
with 821 similar patients who received only medical treatment (Fig. 7).
The five-year survival in the LAP-BAND®-treated group and in the
medically-treated group is shown in Fig. 8, where a statistically significant
difference in survival can be clearly seen in favour of the surgical group.
120
M. De Luca et al.
Matching for Sex (M / F)
Age (less 40, 40–49, 50–59, 60–69, more than 70)
and BMI (40–44, 45–49, 50+)
4640 patients (BMI > 40)
in 6 Italian Medical Centers (1976–1996)
1015 patients treated by LapBand
Obesity Center of Padua
(1994–2001)
1388 pts treated after 1994
821 pts with BMI > 40
821 pts treated by Lap Band
821 pts treated by medical therapy
Figure 7.
Case/control study involving 821 patients of our LapBand series and 821
patients treated by medical therapy in other Italian Medical Centers matching and selec-
tion of patients in the Case Group and Control Group.
Kaplan–Meier survival curves were calculated at six months and at
one, two, three and five years and differences in survival between groups
evaluated by logrank test. The survival rate was significantly higher in the
LAP-BAND® group (p < 0.0007).
Relative risk of death after adjustment for sex, age and BMI in the
surgical group was 0.38 (95 per cent CI: 0.17–0.85). So, the surgically-
treated group is shown to have a 60 per cent reduction in total mortality.
Conclusion
LAP-BAND® System placement is proved to be a safe, effective, and
gentle procedure which enables major and durable weight loss with
improvement of a broad range of co-morbidities. It is quickly performed,
well accepted by patients, with low mortality and mild complications
which very rarely become lethal.
There are some clear requirements for the successful use of the LAP-
BAND®. Though these requirements are not difficult or unusual, they are
essential. The surgeon needs to have good laparoscopic skill and bariatric
experience. Reasonable competence and experience can be achieved
with good, specifically-oriented training and proctoring. There must be a
Long-Term Results in Laparoscopic Adjustable Gastric Banding
121
Figure 8.
Five years survival in the lapband- and medical-treated groups.
commitment to the patients, to their education and support, to their ongo-
ing routine care and problems. This commitment is best realized in the
presence of a multidisciplinary support team (dietician, psychologist,
internist and surgeon).
It is no accident that gastric banding is the most commonly performed
bariatric surgery in the world. As our data indicate, the LAP-BAND®
Adjustable Gastric Banding procedure is safe and effective for the treat-
ment of both morbidly obese and super-obese patients in the short,
medium and long term. In experienced hands the complication rate is low
and significant, stable weight loss to at least 12 years can be the norm.
Other bariatric procedures that are fixed at the time of surgery cannot
compete with gastric banding in the long-term. The adjustability feature
of the LAP-BAND® allows patients to continue losing weight and to
maintain lost weight over time. Of course, intensive follow-up and regu-
lar stoma adjustments must be a strictly enforced part of the process as
they are integral to the patients’ success.
References
1. Buchwald, H. (2005). Consensus Conference Statement — bariatric surgery
for morbid obesity: health implications for patients, health professionals and
third-party payers. Surg Obes Relat Dis 1: 371–381.
2. Favretti, F., Cadière, G., Segato, G. et al. (2002). Laparoscopic banding:
selection and technique in 830 patients. Obes Surg 12: 385–390.
3. Fielding, G., Allen, J. (2002). Astep-by-step guide to placement of the lap-band
adjustable gastric banding system. Am J Surg 184(Suppl): 26S–30S.
4. Weiner, R., Engert, R., Weiner, S. et al. (2003). Outcome after laparoscopic
adjustable gastric banding – 8 years experience. Obes Surg 13: 427–434.
5. Busetto, L., Segato, G., De Luca, M., et al. (2004). Preoperative weight loss
by intragastric balloon in super-obese patients treated with laparoscopic gas-
tric banding: a case-control study. Obes Surg 14: 671–676.
6. National Institutes of Health Consensus Development Conference Draft
Statement (1991). Gastrointestinal surgery for severe obesity. Obes Surg 1:
257–266.
7. Busetto, L., Sergi, G., Enzi, G.I. et al. (2004). Short term effects of weight loss on
the cardiovascular risk factors in morbidly obese patients. Obes Res 12(8): 1–8.
122
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8. Dargent, J. (2004). Surgical treatment of morbid obesity by adjustable gas-
tric band: the case for a conservative strategy in the case of failure — a
9-year series. Obes Surg 14: 986–990.
9. Chevallier, J.-M., Zinzindohoue, F., Douard, R. et al. (2004). Complications
after laparoscopic adjustable gastric banding for morbid obesity: experience
with 1,000 patients over 7 years. Obes Surg 14: 407–414.
10. Parikh, M.S., Fielding, G.A., Ren, C.J. (2005). U.S. experience with 749
laparoscopic adjustable gastric bands: intermediate outcomes. Surg Endosc
19(12): 1631–1635.
11. Cadière, G.B., Favretti, F., Himpens, J. (2001). Anneau gastrique et deriva-
tion bilio-pancreatique par laparoscopie. J Coelio-Chir 38: 32–35.
12. Ponce, J., Paynter, S., Fromm, R. (2005). Laparoscopic adjustable gastric
banding: 1,014 consecutive cases. J Am Coll Surg 201(4): 529–535.
13. Favretti, F., Cadière, G., Segato, G. et al. (1997). Laparoscopic adjustable sil-
icone gastric banding (LAP-BAND ®): how to avoid complications. Obes
Surg 7: 352–358.
14. O’Brien, P., Dixon, J. (2002). Weight loss and early and late complications —
the international experience. Am J Surg 184(Suppl): 42S–45S.
15. Belachew, M., Belva, P.H., Desaive, C. (2002). Long-term results of laparo-
scopic adjustable gastric banding for the treatment of morbid obesity. Obes
Surg 12(4): 564–568.
16. Parikh, M., Laker, S., Weiner, M. et al. (2006). Objective comparison of
complications resulting from laparoscopic bariatric procedures. J Am Coll
Surg 202: 252–261.
17. Favretti, F., Segato, G., Ashton, D. et al. (2007). Laparoscopic adjustable gas-
tric banding in 1,791 consecutive obese patients: 12-year results. Obes Surg
17: 168–175.
18. O’Brien, P.E., Dixon, J.B., Laurie, C. et al. (2005). A prospective rand-
omized trial of placement of the laparoscopic adjustable gastric band:
comparison of the perigastric and pars flaccida pathways. Obes Surg 15(6):
820–826.
19. Goldstein, D.J. (1992). Beneficial health effects of modest weight loss. Int J
Obes Relat Metab Disord 16(6): 397–415.
20. Busetto, L., Mazza, M., Mirabelli, D. et al. (2006). Total mortality in morbid
obese patients treated with laparoscopic adjustable gastric banding: a case-
control study. Obes Metab 2(Suppl): 365 (abst).
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Chapter 6
Laparoscopic Adjustable Gastric Banding
(LAP-BAND®): Diagnosis, Prevention
and Treatment of Complications
Maurizio De Luca, Luca Busetto, Gianni Segato,
Nadey S. Hakim and Franco Favretti
Introduction
Laparoscopic adjustable gastric banding using the LAP-BAND®
(Allergan Inc., Irvine, CA, USA) has been performed in our institution
since 1993.1,2
In the past ten years the procedure has gained widespread acceptance
and is now the most frequently performed bariatric procedure in many
countries of the world.
Laparoscopic adjustable gastric banding brings many advantages to
patient and surgeon. The procedure is completely reversible as it does not
require the opening of the gastrointestinal tract or rerouting of the
anatomy and it does not rely on cutting or stapling of the stomach so the
patient does not suffer from the resultant, sometimes serious complica-
tions. Laparoscopic adjustable gastric banding (LAGB) has the distinction
of being the only bariatric operation designed to be performed laparo-
scopically (the operation is laparoscopically accomplished in > 98 per cent
of all cases). LAP-BAND® therefore allows patients to leave the hospital
much earlier than more drastic open bariatric procedures, and subjects can
return to work and normal activity much sooner.2–8
125
126
M. De Luca et al.
Complications with LAP-BAND® are unavoidable; they can be
treated by laparoscopy in most cases and are rarely life-threatening if
managed appropriately.
It is worthwhile noting that as techniques for placement have evolved,
complication rates with the LAP-BAND® have declined. Surgeons and
patients should adopt strategies that will help avoid complications and be
sensitive to any indications of their emergence.9–17
In this chapter we report the long-term outcome of a large group of
morbidly obese patients treated with the LAP-BAND®. We focus on the
complications that required revisional surgery and present our methods of
diagnosis, prevention and treatment.
Lap-Band® Series at Vicenza Regional Hospital, Padua
Our total series consisted of 2,225 patients between September 1993 and
November 2007; we analyzed a subset of 1,800 patients with a follow-up
rate of 91 per cent.
Between September 1993 and December 2005, the same surgical
team performed LAP-BAND® procedures on 1,800 consecutive patients
(75.1 per cent women, mean age 38.7 years, mean body weight (BW)
127.7 ± 24 kg, mean body mass index (BMI) 46.2 ± 7.7). Perigastric dis-
section was used in 77.8 per cent of the patients while pars flaccida was
used in 21.5 per cent and a mixed approach in 0.8 per cent. Patients’ data
were analysed according to co-morbidities, conversion, short and long
term complications and weight loss. Fluoroscopy-guided adjustments
were performed and patients received intensive follow-up.1
Most common baseline co-morbidities were hypertension (35.6 per
cent), osteoarthritis (57.8 per cent), diabetes (22 per cent), dyslipidaemia
(27.1 per cent), obstructive sleep apnoea syndrome (OSAS) (31.4 per
cent), depression (21.2 per cent), sweet eating (22.5 per cent) and binge
eating (18.5 per cent). Conversion to open surgery was 1.7 per cent, of
which 1.2 per cent was due to technical difficulties and 0.5 per cent to
intraoperative complications. Together with the positioning of the band
additional surgery was performed in 11.9 per cent of the patients: hiatal
hernia repair (2.4 per cent), cholecystectomy (7.8 per cent) and other
procedures (1.7 per cent). The mortality rate was 0 per cent. The follow up
rate is 91 per cent. Band related complications, not all requiring reopera-
tion, occurred in 230 patients. (12.8 per cent): pouch dilation 132 (11.7 per
cent), slippage 77 (4.3 per cent), erosion 20 (1.1 per cent), infection
1 (0.1). Reoperations were required for 123 patients (6.8 per cent): band
removal 69 (3.9 per cent) and band repositioning 54 (3.0 per cent). Port
related complications occurred in 200 patients (11.2 per cent).
The BW (kg) was 103.7 ± 21.6, 102.5 ± 22.5, 105.0 ± 23.6, 106.8 ±
24.3, 103.3 ± 26.2 and 101.4 ± 27.1 at 1, 3, 5, 7, 9, 11 years after surgery.
The BMI, at the same intervals, was 37.7 ± 7.1, 37.2 ± 7.2, 38.1 ± 7.6,
38.5 ± 7.9, 37.5 ± 8.5 and 37.7 ± 9.1.1
Complications
The LAP-BAND® operation is not without complications, but these occur
on a smaller scale and have a much lower risk profile compared to other
methods currently used in obesity surgery. It is important to note that
complications can usually be corrected and that the LAP-BAND® appears
to be the lowest risk operation currently available for the treatment of
morbid obesity. Another important aspect of this kind of surgery, even
though it requires advanced laparoscopic experience, is that most of the
complications can be corrected by laparoscopy.
The following are the most common complications of LAP-BAND®:
1.
Gastric perforation;
2.
Stomach slippage;
3.
Stoma obstruction;
4.
Oesophageal and gastric pouch dilatation;
5.
Erosion;
6.
Gastric necrosis;
7.
Tubing/access port problems;
8.
Lack of compliance/unsatisfactory result.
Gastric perforation
The stomach may be perforated during surgery, mainly at the creation of
the retrogastric tunnel. This step can be difficult in patients with very high
BMI, visceral obesity and especially in males.16–18
Diagnosis, Prevention and Treatment of Complications
127
Causes
The relationship of this ‘gastric perforation’ to the surgical procedure is
evident and emergency surgery is indicated.
Incidence
Most surgeons have reported one or two stomach perforations, primarily
during the learning curve period with a gastric perforation rate ranging
from 0.2 to 3.5 per cent.
Symptoms
Gastric perforation is characterized by free leakage of gastric contents into
the peritoneum similar to when perforation of the gastric lining leads to
peritonitis.
Diagnosis
This complication can be detected easily during surgery by inflating the
stomach with a methylene blue solution once the band tubing has been
pulled into the retrogastric tunnel. Utilizing the methylene blue after the
band has been positioned and locked could be useless. In fact, the band
might completely fill the perforation and not show any leakage. An upper
GI X-ray series with gastrographin, done routinely on the first post-
operative day, can show the perforation.
How to avoid it
During the creation of the retrogastric tunnel there is in any patient a
‘blind area’. If we want to avoid this complication, the area can be
reduced by a wider downward exposition of the left crus and by a wider
dissection along the lesser curvature. This is a consideration if the ‘peri-
gastric’ dissection path is utilized. To avoid gastric wall injuries the
calibration tube must be withdrawn during dissection and should be
undertaken perpendicularly so as not to enter the inferior mediastinum
128
M. De Luca et al.
along the oesophagus. We have found that the Articulating Dissector
(Automated Medical Products Corp., Edison, NJ, USA) is atraumatic
enough to avoid damaging the gastric wall. Good surgical technique with
adequate exposure and use of appropriate instruments can reduce the
incidence of this serious complication.
If the retrogastric dissection turns out to be risky, a very valuable
option is the video-hand-assisted technique. The right hand of the surgeon
is introduced into the abdomen through a mini-laparotomy. The perigastric
dissection is undertaken digitally using the in-place calibration tube as a
reference. The articulating instrument is put in place, the mini-laparotomy is
closed and the rest of the operation is completed, usually by laparoscopy.
Treatment
If the perforation is detected at surgery and if it occurs at a location dis-
tant from the band, some surgeons have repaired the stomach
laparoscopically and placed the band successfully. But, if the exposure is
not satisfactory it is advisable to postpone the placement of the band,
suture the stomach wall, drain the area and have a naso-gastric tube in
place. If the perforation is detected post-operatively, and gross contami-
nation has already occurred causing peritonitis and subsequent emergency
surgery, the band has to be removed and traditional surgical approaches
have to be implemented.
Stomach slippage
Stomach slippage is the post-operative development of an overly-large
upper gastric pouch. Often referred to as gastric prolapse and often con-
fused with pouch dilatation, this complication can occur anteriorly and/or
posteriorly.16,17,19
Causes
Posterior gastric slippage is the most common type. The posterior gastric
wall moves through the band resulting in the creation of a large posterior
pouch. The band rotates to a vertical position, or even rotates beyond
Diagnosis, Prevention and Treatment of Complications
129
vertical, with the inferior aspect of the band lying more to the left. This
problem is principally a consequence of placing the band across the apex
of the lesser sac rather than through the tissue above the lesser sac.
Anterior gastric slippage results from failure of the anterior fixation
(retention sutures). The band moves to a horizontal position and the
enlarged proximal stomach overlies the left side of the band. The sutures
may be placed in a way that fails to fix the lateral (greater curvature)
aspect. They may be insufficient in number to give full fixation or they
may be inserted above the band into the fat pad overlying the oesophago-
gastric junction rather than into the upper gastric wall, so they
subsequently tear out. Both posterior and anterior pouch dilatation lead to
excessive stomach tissue inside the band and to obstruction between the
upper pouch and the lower stomach.
Incidence
This is the most frequent complication associated with the LAP-BAND®
procedure. Its incidence has been dramatically reduced over the years
(from as high as 22 per cent down to less than 5 per cent by a better under-
standing of the anatomy of the gastro-oesophageal junction and by the
evolution of the surgical technique).
Three techniques for the positioning of the LAP-BAND® have been
described:
1.
the perigastric method (Fig. 1);
2.
the pars flaccida method (Fig. 2);
3.
the pars flaccida to perigastric technique (Fig. 3).
Of these the perigastric technique may have the highest rate of slippage,
probably because it is more difficult to master. But in fact the perigastric
technique, properly performed, has a very low incidence of slippage, 10 per
cent in our series, of which 1.9 per cent required reoperation.
Symptoms
Stomach slippage should be suspected when patients who have had a
normal post-operative period begin to experience changes in their eating
130
M. De Luca et al.
habits. The symptoms of slippage are those of partial or complete obstruc-
tion and of fluid stasis in the lower oesophagus and upper distended
gastric pouch. They include:
•
heartburn;
•
vomiting;
•
free reflux of fluid into the mouth;
Diagnosis, Prevention and Treatment of Complications
131
Figure 1.
Peri-gastric technique. The dissection starts directly on the lesser curve at the
mid-point (equator) of the calibration balloon. Dissection is completed behind the stom-
ach towards the angle of His under direct visualization. Avoidance of the lesser sac is
important. Retro-gastric suturing is an option.
Red = direction of dissection; blue = LAP-BAND® System placement
Figure 2.
Pars flaccida technique. Dissection begins directly lateral to the equator of the
calibration balloon in the avascular space of the pars flaccida. After seeing the caudate
lobe of the liver, blunt dissection is continued under direct visualization until the right crus
is seen, followed immediately by the left crus over to the angle of His.