Surgery for Obesity and Related Diseases 5 (2009) 38 – 42
Original article
Adjustable gastric band placed around gastric bypass pouch as revision operation for failed gastric bypass Philip L. Chin, M.D.*, Mir Ali, M.D., Kelly Francis, M.D., Peter C. LePort, M.D. Smart Dimensions and Lite Dimensions Surgical Weight Loss, Fountain Valley, California Received May 2, 2008; revised August 12, 2008; accepted August 14, 2008
Abstract
Background: The failure rate after gastric bypass surgery for weight loss has been reported at 10 –20%. To date, no reliably safe and effective salvage operation is available. This pilot study was conducted to determine whether restriction of the Roux-en-Y gastric bypass (RYGB) pouch using the adjustable gastric band (AGB) is an effective revision operation. Methods: A prospectively accrued group of patients who underwent revisional surgery using the AGB placed around the RYGB pouch by our bariatric surgical group from October 2004 to October 2006 was analyzed. Results: Of the 10 patients accrued during this period, 2 were lost to follow-up, leaving 8 patients for analysis. Of the 8 patients, 1 was a man and 7 were women. The mean prerevision weight was 135.75 kg (range 105–165), and the body mass index was 48.42 kg/m2 (range 38.92–55). The mean weight loss at 1 year of follow-up was 17.03 kg (range 0.2– 42), with a mean percentage of excess weight loss of 24.29% (range 0.2– 49.2%). The mean weight loss of the 5 patients with 2 years of follow-up was 36.4 kg (range 20 –58), with a mean percentage of excess weight loss of 48.7% (range 21.8 –98.1%). One patient with 3 years of follow-up had a weight loss of 56 kg and a percentage of excess weight loss of 66.2%. Three minor complications developed: 2 AGB port-related complications requiring port revision and 1 postoperative wound hematoma requiring evacuation. No band erosions or band slippages occurred, and no major complications developed. Conclusion: In our study, an AGB placed around the RYGB pouch was a safe and effective revision operation for a failed RYGB operation. (Surg Obes Relat Dis 2009;5:38 – 42.) © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved.
Keywords:
Bariatric surgery; Morbid obesity; Revision surgery; Adjustable gastric band; Gastric bypass failure
The Roux-en-Y gastric bypass (RYGB) is currently the most commonly performed bariatric operation in the United States [1]. First developed by Mason and Ito [2] in 1967, the RYGB has had excellent long-term results and safety. Despite its success, the RYGB has a reported failure rate of 10 –20% [3,4], with patients failing to achieve 50% excess weight loss (EWL) or a body mass index of ⬍35 kg/m2 after surgery or subsequently regaining weight after initial success.
Presented at the 25th Annual Meeting of the American Society for Metabolic; Bariatric Surgery; 15–20 June 2008 in Washington DC *Reprint requests: Philip L. Chin, M.D., 11160 Warner Avenue, Suite 421, Fountain Valley, CA 92708. E-mail:
[email protected]
The causes for late failure have included staple line disruption with subsequent fistula formation between the RYGB pouch and the distal excluded stomach, dilation of the RYGB pouch, and enlargement of the gastrojejunal stoma. Various revisional operations have been proposed, including conversion to long-limb RYGB or biliopancreatic diversion/duodenal switch, as well as revision of the original RYGB pouch or stoma. These procedures, however, have had limited success and are associated with significant morbidity [5,6]. With increasing experience in the use of the adjustable gastric band (AGB), we wished to exploit its unique attributes in the revisional bariatric surgery population. Technically straightforward to apply, avoiding transection or anastamosis of gastrointestinal structures, as well as being easily reversible
1550-7289/09/$ – see front matter © 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved. doi:10.1016/j.soard.2008.08.012
P. L. Chin et al. / Surgery for Obesity and Related Diseases 5 (2009) 38 – 42
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and adjustable, the AGB might have advantages compared with other revision operations in terms of efficacy and safety. We report our experience using the AGB placed around the RYGB pouch as a revision operation for failed RYGB. Methods All patients treated by our bariatric surgical group were entered prospectively into an electronic database starting in 2004. From October 2004 to October 2006, 10 patients were identified who had undergone previous RYGB that had failed and who subsequently underwent revision with an AGB placed around the RYGB pouch. Failure of RYGB was defined as remaining morbidly obese (body mass index ⬎35 kg/m2) at 18 months after RYGB or regaining weight after initial successful EWL of 50% at 18 months after RYGB. Patients who met the criteria for RYGB failure were given the option of an AGB placed around the RYGB pouch as a revision operation. The patients were extensively counseled regarding the potential risks and benefits of the operation, as well as the limited reported experience of the AGB used as a revision operation for failed RYGB. The patients underwent extensive preoperative instruction and assessment, including nutritional teaching, psychological assessment, support group attendance, history and physical examination, laboratory testing, and radiologic testing similar to that for patients presenting to our group for a primary bariatric operation. All patients presenting for revision also underwent upper gastrointestinal radiographic examination and, in some instances, upper endoscopy to evaluate the anatomy of the initial RYGB. Postoperatively, the patients were evaluated for AGB adjustment at 6 weeks and again at 6 – 8-week intervals, as needed. The outcome measures include perioperative and postoperative complications, weight loss (expressed in kilograms and as the percentage of EWL), and resolution/ improvement of co-morbidities. The reported values are expressed as the mean and standard deviation. All patients underwent placement of the AGB by open laparotomy. The abdomen was approached using a midline upper abdominal incision, usually corresponding to the patient’s previous incision scar. Careful adhesiolysis was then performed to identify the gastric pouch and gastrojejunal anastamosis. Exposure was provided using a bariatric Omni retractor. A BioEnterics calibration tube (Allergan, Santa Barbara, CA) was then placed by the anesthesiologist into the gastric pouch. The peritoneum and scar tissue at the angle of His was then carefully opened. The peritoneum and scar tissue at the gastrohepatic ligament was then opened, exposing the diaphragmatic crus. A laparoscopic dissector was passed posterior to the stomach using the pars flaccida technique from the lesser curve of the stomach to the angle of His, and the Lap-Band (Allergan) was passed around the RYGB pouch in the conventional manner. The decision to use the standard size or the
Fig. 1. Laparoscopic AGB around RYGB pouch.
larger Vanguard Lap-Band was at the discretion of the operating surgeon. The AGB was situated around the RYGB pouch above the gastrojejunal anastamosis with inflation and positioning of the orogastric calibration tube, confirming appropriate placement around the proximal stomach rather than the esophagus (Fig. 1). Plication of the AGB was performed selectively depending on the patient’s anatomy. If RYGB pouch dilation provided redundant stomach, this was plicated over the band with interrupted 2-0 Ethibond sutures. If the RYGB pouch was of a normal small size, the distal excluded stomach was used to plicate the AGB. In several cases, the perigastric adhesions were extensive, with significant fixation of the stomach to the spleen or other adjacent structures. It was thought in these situations that dissection to free up the stomach to plicate it over the band would lead to an increased risk of hemorrhage or inadvertent enterotomies and, because significant fixation of the distal stomach was present already, no plication was performed. Another consideration was that plication appeared in some instances to kink the gastrojejunal anastamosis. To avoid possible obstructive complications, no plication was performed. The port of the AGB was then fixed to the anterior rectus sheath through a separate incision in the left upper abdomen. Results All patients in our series had undergone their original RYGB as an open procedure. Most of the original opera-
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P. L. Chin et al. / Surgery for Obesity and Related Diseases 5 (2009) 38 – 42
Table 1 Patient data at original RYGB Pt. No.
Gender
Weight at RYGB (kg)
BMI at RYGB (kg/m2)
Lowest weight achieved (kg)
Lowest BMI achieved (kg/m2)
Maximal EWL (%)
Weight regain (kg)
1 2 3 4 5 6 7 8 Mean
Female Female Female Female Female Female Female Male
171 141 255 210 125 158 168 170 174.8
66.7 60.5 85.2 76.7 50.3 52.8 53.1 55.4 62.6
132 89 124 114 80 90 145 161 116.9
46.8 38.1 41.5 41.6 32.0 30.3 45.9 52.4 41.1
36 61 69 65 67 73 23 9 50.4
15 22 33 21 25 26 5 4 18.9
tions were performed at other institutions, but all RYGB procedures were proximal (Roux limb ⬍150 cm), nondivided and nonbanded RYGB. The patient data at the original RYGB are presented in Table 1. Of the 10 patients undergoing the revision operation of an AGB placed around the RYGB pouch from October 2004 to October 2006, 2 were lost to follow-up, never returning for postoperative their evaluations, leaving 8 patients for analysis. Of these 8 patients, 1 was a man and 7 were women. At the revision operation, the mean age of the patients was 51.38 ⫾ 8.93 years, with a mean prerevision weight of 135.75 ⫾ 22.63 kg and mean body mass index of 48.42 ⫾ 5.25 kg/m2. The mean interval from the original operation was 90.5 ⫾ 43.02 months. Most patients had no grossly reported abnormalities identified by the preoperative radiologic or endoscopic studies, with the pouch size and gastrojejunal anastamosis diameter reported as normal. Two patients had findings suggestive of an enlarged gastric pouch measuring ⬎5 cm in size or a wide anastamosis ⬎1 cm in diameter. No staple line breakdown or pouch-to-distal-stomach fistula was reported. All revision operations were performed using open laparotomy. One patient underwent an attempt at laparoscopic placement of the AGB; however, on introduction of the laparoscopic camera, the patient was found to have extensive adhesions, necessitating conversion to an open operation. In 2 patients, additional operations were performed at revision: 1 patient underwent incisional herniorrhaphy with mesh and 1 patient underwent cholecystectomy. Of the 8 patients, 5 underwent placement of the standard-size LapBand and 3 placement of the larger Vanguard Lap-Band. Plication of the AGB was performed in 4 patients: 3 using the distal excluded stomach and 1 using redundant RYGB pouch. Four patients had no plication performed. The mean operative time was 113.25 ⫾ 31.85 minutes. No immediate perioperative complications developed. Three minor postoperative complications developed. Two patients required port site revision because of a flipped port and the inability to access a port (at 5 and 14 months after the revision operations, respectively), and 1 patient devel-
oped a wound hematoma requiring incision and drainage (3 months after the revision operation). The latter patient had undergone mesh prosthetic repair of an incisional hernia concurrent with her revision operation. No band erosions or band slippages or other major complications have developed to date. The patients were evaluated at 6 – 8-week intervals for AGB adjustment. All AGB adjustments were performed in the office without fluoroscopy, except for 1 patient who had difficult port access, requiring adjustments under fluoroscopy, and who eventually underwent port site revision. At 1 year, a mean of 4 ⫾ 1.85 adjustments had been done per patient, with a mean volume of 2.66 ⫾ 0.61 mL for the standard size and 5.5 ⫾ 1.5 mL for the Vanguard LapBands. In the 5 patients with 2 years of follow-up, a mean of 5.6 ⫾ 2.3 total adjustments per patient had occurred, with a mean volume of 3.1 ⫾ 1.47 mL in the standard size and 6 ⫾ 1.41 mL in the Vanguard Lap-Bands. The 1 patient with 3 years of follow-up had had a total of 8 adjustments, with 3.7 mL in a standard size Lap-Band. No patients had complaints of persistent vomiting or dysphagia. At the 1-year follow-up visit, the mean weight loss for the 8 patients was 17.03 ⫾ 12.58 kg, with a mean EWL of 24.29% ⫾ 16.14%. For the 5 patients with 2 years of follow-up, the mean weight loss was 36.4 ⫾ 18.28 kg, with a mean EWL of 48.7% ⫾ 33.34%. The 1 patient with 3 years of follow-up had a weight loss of 56 kg and EWL of 66.2% (Table 2). Patients reported co-morbidities of diabetes, hypertension, and sleep apnea at their revision operations. Of the 2 patients with diabetes, both reported resolution at their last follow-up evaluation. Of the 4 patients with hypertension, 2 reported resolution at their last follow-up visit. Finally, of the 5 patients with sleep apnea, 3 no longer required continuous positive airway pressure at their last follow-up visit. Discussion Reoperative surgery after failed RYGB has, in the past, had limited success or has been associated with significant morbidity. The main indication for revision surgery is a
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Table 2 Patient demographics and results Pt. No.
1 2 3 4 5 6 7 8 Mean
Age at revision (y)
Weight at revision (kg)
BMI at revision (kg/m2)
Interval from original surgery (mo)
Revision operation
41 46 42 55 53 51 69 54 51.4
147 111 157 135 105 116 150 165 135.8
52.2 47.7 52.6 49.9 43.5 38.9 47.5 55 48.4
54 120 120 68 78 106 156 22 90.5
Open/Chole Open/hernia Open Open VG Lap-open Open Open VG Open VG
EWL (%)/BMI (kg/m2) At 1 y
At 2 y
At 3 y
49.2/37.4 38.5/37.2 25.1/44.9 7.4/47.4 33.1/35.7 24.1/34.7 0.2/47.1 16.7/48.3 24.3/41.6
68.4/31.6 98.1/23.5 28.8/43.7 26.4/42.3
66.2/32.3
21.8/46.8 48.7/37.6
Pt. No. ⫽ patient number; Open ⫽ open standard Lap-Band placed around RYGB pouch; Open VG ⫽ open Vanguard Lap-Band placed around RYGB pouch; Chole ⫽ cholecystectomy; hernia ⫽ incisional herniorrhaphy; Lap-open ⫽ attempted laparoscopic conversion to open Lap-Band placed around RYGB pouch.
failure to lose weight or regaining weight after initial success with RYGB. The failure rate has been estimated to be approximately 10 –20% [3]. The main mechanical causes of RYGB failure include staple line failure, gastric pouch dilation, and gastrojejunal stomal dilation. During preoperative evaluation for RYGB failure, however, specific mechanical causes for failure might not be readily identified. Only a minority of our patient population demonstrated radiologic or endoscopic findings suggestive of pouch or stomal dilation, with most having study findings interpreted as a normal-size RYGB pouch or stoma. None of our patients had a staple line disruption. The dilemma for the bariatric surgeon is how to address this group of RYGB patients with failure to lose weight and in whom no definite mechanical cause can be identified. Conversion of the RYGB to a distal RYGB or biliopancreatic diversion/duodenal switch has been reported. Sugerman et al. [7] reported on 22 patients who had undergone conversion from proximal to distal RYGB for failed RYGB. Although these patients were able to achieve long-term weight loss, this malabsorptive operation was associated with fat-soluble vitamin, calcium, iron, and protein-calorie deficiencies requiring life-long supplements and close monitoring of the various parameters. These operations can also be associated with major complications, including leak rates as great as 15% for conversion to biliopancreatic diversion/ duodenal switch [8]. Other reports on revision operations for RYGB failure have noted the relatively disappointing outcomes and high morbidity. Schwartz et al. [9] noted a 33% EWL at 2 years of follow-up after RYGB revision. Behrns et al. [10] noted only an overall weight loss of 16 ⫾ 3 kg after revision surgery. Hunter et al. [5] found that only 23% of patients at 2 years of follow-up after revision surgery were judged to have had a successful result. In addition, all these studies noted high complication rates, ranging from 10% to 50%. The AGB would appear to offer many benefits to the
revision bariatric population. From a technical standpoint, the placement is straightforward—no stapling of the stomach or creation of an anastamosis is required, significantly reducing the risk of leak or inadvertent enterotomy. It can be placed laparoscopically or using an open approach. The AGB is adjustable and easily reversible. Other groups have reported on the use of the AGB as a revision operation for failed bariatric operations. O’Brien et al. [11] reported on the use of the Lap-Band as a revision operation for a variety of previous bariatric procedures, including 2 patients with failed RYGB. Although more perioperative adverse events occurred compared with primary Lap-Band placement, the late complications were fewer and the weight loss and resolution of co-morbidities were comparable to those after primary Lap-Band placement. Kyser et al. [12] reported comparable results in their series of patients, including 12 RYGB patients. Although these series used open laparotomy for placement of the AGB, good results with a laparoscopic approach to various types of bariatric reoperative surgery have been reported [13]. Bessler et al. [14] reported good results with the addition of adjustable silicone gastric banding to RYGB in 8 patients. Although their initial 3 patients underwent laparotomy to place the bands, subsequent patients were operated on laparoscopically. Gobble et al. [15] noted an additional 20.8% EWL after AGB placement for failed RYGB in their series of 11 patients. Our results showed a comparable efficacy to these studies using AGB placement as a revision operation for failed RYGB. In addition to achieving effective weight loss, our series noted only minor complications, with 2 port-related complications and 1 wound-related complication that was more likely associated with the hernia repair than with the AGB. No major AGB complications were noted, such as band erosion or band slippage. The lack of band slippage is notable in that 4 patients did not have any plication of the AGB performed because of the presence of significant adhesions. It is likely that the presence of these adhesions provided fixation of the stomach, decreasing the likelihood
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of band slippage and gastric herniation. It is unclear whether the presence of the gastrojejunal anastamosis provided another area of fixation, decreasing the possibility of band slippage. However, our revision population had all undergone open primary operations during the prelaparoscopic bariatric era. In the future, as more laparoscopic RYGB patients have weight loss failure, plication and fixation of the AGB might be of more importance in light of the significantly fewer adhesions generated by their primary operation. An additional consideration is that laparoscopic, rather than open revision operations could be more technically straightforward and feasible when used for revision of laparoscopic primary operations, for similar reasons. Conclusion The use of the AGB placed around the RYGB pouch for failed RYGB is a technically simple operation with a low risk of perioperative complications. In our intermediate follow-up, it provided effective weight loss and resolution or improvement of co-morbidities. It was also associated with low rates of late complications. Disclosures The authors claim no commercial associations that might be a conflict of interest in relation to this article. References [1] Buchwald H, Williams SE. Bariatric surgery worldwide 2003. Obes Surg 2004;14:1157– 64.
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