1 2 3 Surgery for Obesity and Related Diseases ] (2017) 00–00 4 5 6 Original article 7 8 Q3 9 10 Q4 11 Sergio Carandina, M.D.a,b,*, Laurent Genser, M.D.c, Manuela Bossi, M.D.a, Claude Polliand, M.D.a, 12 13 Q1 Malek Tabbara, M.D.a, Christophe Barrat, M.D., Ph.D.a 14 Q5 aAssistance Publique-Hôpitaux de Paris (AP-HP), Department of Digestive and Metabolic Surgery, Avicenne University Hospital. Centre Intégré Nord Francilien de la Prise en Charge de l’Obésité (CINFO). Université Paris XIII-UFR SMBH “Léonard de Vinci”, AP-HP, Bobigny, France 15 b Department of General and Bariatric Surgery, Clinique Bouchard, Marseille, France 16 c Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Digestive and Hepato-Pancreato-Biliary Surgery, Liver Transplantation, Pitié-Salpêtrière 17 University Hospital, Pierre & Marie Curie University, Paris, France 18 Received December 21, 2016; accepted February 12, 2017 Q6 19 20 21 Abstract Background: Laparoscopic sleeve gastrectomy (LSG) has become a valuable surgical option to 22 rescue laparoscopic adjustable gastric banding (LAGB) failures. 23 Objectives: The aim of this study was to determine whether conversion to LSG after failed LAGB 24 (CLSG) is a well-tolerated and effective rescue procedure compared with primary LSG (PLSG) in 25 the long term. Setting: University hospital, France. 26 Methods: A retrospective review of data concerning consecutive patients receiving a LSG between 27 February 2008 and December 2014 was conducted. Mortality, postoperative complications, and 28 weight loss outcomes were analyzed. 29 Results: Of 701 LSG, 601 (85.7%) were PLSG and 100 (14.3%) were CLSG. The mortality rate 30 was 0%. Overall morbidity was comparable between the primary and conversion group (10% versus 31 6%, P ¼ .27). The mean percentage of excess weight loss at 3, 36, and 72 months was 34.9%, 32 72.1%, and 57.2% after PLSG and 22.6%, 51.2% and 29.8% after CLSG (P o .05). The failure rate 33 (mean percentage of excess weight loss o50%) was higher in the CLSG group during the first 5 34 postoperative years (P o .001) with more than two thirds of the CLSG considered as having failed 35 at 60 months. Patients who underwent band ablation as a result of insufficient weight loss or weight 36 regain presented the worst results after conversion to LSG. Conclusion: In this study, the conversion of failed LAGB to LSG in 2 steps indicated a safety 37 profile comparable to that of primary LSG but was significantly less effective from the early 38 postoperative course (3 mo) up to 6 years postoperatively. CLSG may not be the best option because 39 a third operation may be needed as a result of insufficient weight loss. (Surg Obes Relat Dis 40 2017;]:00–00.) r 2017 American Society for Metabolic and Bariatric Surgery. All rights reserved. 41 42 Keywords: Gastric banding failure; Sleeve gastrectomy; Long-term results; Rescue procedure; 2-step procedure 43 44 45 46 47 48 Preliminary results of this work have been presented to: The 20th Congress of the International Federation for the Surgery of Obesity and Metabolic 49 Disorders (IFSO) in Vienna, Austria, August 26–29, 2015 (Poster Session); and the 32nd Annual Meeting of the ASMBS at ObesityWeek 2015 (Top 15 50 Poster Session; Friday, November 6, 2015). * Corresponding author: Sergio Carandina, M.D., Avenue de Stalingrad, 93100 Bobigny, Paris, France. Tel.: þ33 6 77593954. 51 E-mail:
[email protected] 52 53 http://dx.doi.org/10.1016/j.soard.2017.02.008 54 1550-7289/r 2017 American Society for Metabolic and Bariatric Surgery. All rights reserved. 55
Laparoscopic sleeve gastrectomy after failed gastric banding: is it really effective? Six years of follow-up
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Laparoscopic adjustable gastric banding (LAGB) has been the most commonly performed bariatric procedure in France for many years [1,2]. Its popularity is due to the relative simplicity of the procedure, morbidity and mortality rate close to zero, and good early results in terms of weight loss [3,4]. However, several studies with long-term followup have reported poor weight loss outcomes and a high failure rate requiring band removal [5–7]. Different surgical options exist to deal with the failure of a gastric banding [8]. Band repositioning or rebanding do not seem to be convincing rescue procedures [9,10]. Currently, conversion to laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the procedure of choice that results in improved weight loss with acceptable morbidity [11,12]. Over the last decade, because of its widespread use, laparoscopic sleeve gastrectomy (LSG) has become another valid surgical option to salvage a gastric banding failure [13–16]. Although a number of studies have been published concerning conversion of failed LAGB to LSG, the majority present results a few months after surgery with low participation in follow-up. Long-term data are missing and no information about its real effectiveness is available. The aim of the present study was to analyze our experience with LSG to evaluate whether it is a well-tolerated and effective rescue procedure after failed LAGB and whether it gives comparable results to those of primary LSG during 7 years of follow-up. Materials and methods We retrospectively reviewed our prospectively collected data on consecutive morbidly obese patients receiving LSG from February 2008 to December 2014 (n = 701 patients). All operations were performed by 2 senior surgeons (C.B. and C.P.). Of the 701 operations, 601 (85.7%) were primary LSG (PLSG) and 100 (14.3%) were LSG performed as a conversion procedure after failed LAGB (CLSG). All the patients underwent a nutritional, psychological, and behavioral evaluation for at least 6 months before being considered valuable candidates for sleeve gastrectomy. An incorrect alimentary behavior that could have been at the origin of band failure was inspected and treated before the conversion. For the present study, we included patients who had received CLSG whether the primary band removal was carried out in our hospital or not. Indications for band removal and conversion were insufficient weight loss or weight regain; band-related complications, including slippage, erosion, infection, and pouch dilation; intractable side effects such as dysphagia, vomiting, and gastroesophageal reflux; and psychological band intolerance. According to Reinhold’s criteria [17], insufficient weight loss after gastric banding was defined as o50% excess weight loss (%EWL), in the absence of band dysfunction. Band-related complications were evaluated via a Gastrografin upper
gastrointestinal contrast study and, if necessary, by endoscopy. All data pertaining to each patient, including demographic data, clinical data, indications for revision, and interval between primary procedure and conversion, were collected. The outcome measures included conversion to open surgery, postoperative complications and mortality, hospital stay, and weight loss over time. Postoperative complications were divided into early complications (within the first 30 d after surgery) and late complications (occurring 41 mo after surgery). Weight loss results were expressed as the change in body mass index (BMI), %EWL and percentage of excess BMI loss (%EBL). The %EWL was calculated as follows: ðpreoperative weight2follow-up weightÞ= ðpreoperative weight2ideal weightÞ 100; where ideal weight was considered as that equivalent to a BMI of 25 kg/m². The %EBL was calculated as follows: ðpreoperative BMI2follow-up BMIÞ=excess BMI 100; where excess BMI was calculated as preoperative BMI 25. In our study, success after LSG was defined as %EWL 450% at every follow-up beyond 1 year. Surgical technique for revisional LSG and postoperative management All surgical procedures were performed in 2 stages and laparoscopically using the same standardized technique. In the first stage, the band was removed and the gastrogastric nonabsorbable plication suture placed on the anterior aspect of the stomach was taken out to restore the normal anatomy of the stomach. The time between band removal and conversion into LSG (second stage) varied between 2 and 6 months in patients operated in our hospital and between 5 months and 10 years in patients who underwent their band removal in other hospitals. Conversional LSG was performed using a 4-port technique. If present, residual adhesions were dissected and any hiatal hernia was closed using sutures. The greater curvature of the stomach was dissected free using a harmonic scalpel (Ethicon Endosurgery Cincinnati, OH), starting opposite the crow’s foot (approximately 6 cm proximal to the pylorus) until the angle of His. LSG was calibrated upon a 36F gastric bougie, pressed along the lesser curvature, and the stomach was transected with sequential firings of linear green and blue staplers (60-mm Echelon, Ethicon Endosurgery, Cincinnati, OH). The staple line was tested using methylene blue dye instilled through a nasogastric tube. A silicon drain was placed alongside the resected line. To rule out leaks, all patients were checked using a methylene blue test and Gastrografin swallow on postoperative day 2 and, if no leakage was detected, an oral fluid diet was started. The patients were discharged on
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Table 1 Baseline characteristics of patients in the PLSG and LAGB to CLSG groups
*
Age, yr Gender, M/F, n (%) Weight, kg* BMI, kg/m²* Excess weight, kg* Type 2 diabetes, n (%) Dyslipidemia, n (%) Hypertension, n (%) OSA, n (%) Severe OSA, CPAP, n (%) Joint disease, n (%) Co-morbidities, n (%) No. of obesity related disease per patient* Operative duration, min* Length of stay, d* Co-morbidities, %
PLSG (n ¼ 601)
CLSG (n ¼ 100)
38.3 ⫾ 11.6 [18–69] 109 (18.1)/492 (81.9) 120.9 ⫾ 21 [59–240] 43.7 ⫾ 6.1 [33.3–74.2] 58.4 ⫾ 17.5 [31.4–158.7] 87 (14.5) 101 (16.8) 156 (26) 233 (38.7) 104 (17.3) 85 (14.1) 404 (67.2) 1.2 ⫾ 1.1 [0–5] 101 ⫾ 21.7 [53–172] 6.2 ⫾ 6.4 [1–60] 52%
41.1 ⫾ 10.6 [23–67] 15 (15)/85 (85) 124.2 ⫾ 27.2 [74–265] 46 ⫾ 8.8 [31.9–77.7] 63.5 ⫾ 24.8 [25.9–184.6] 12 (12) 17 (17) 27 (27) 32 (32) 16 (16) 17 (17) 61 (61) 1.1 ⫾ 1.1 [0–4] 114.8 ⫾ 16.5 [87–180] 6.1 ⫾ 9.4 [2–90] 53%
P .019 .57 .49 .017 .10 .64 1 .81 .22 .88 .45 .25 .57 o.001 .98 .9
BMI ¼ body mass index; CLSG ¼ conversion laparoscopic sleeve gastrectomy; CPAP ¼ continuous positive airway pressure; LAGB ¼ laparoscopic adjustable gastric banding; min ¼ minute; OSA ¼ obstructive sleep apnea syndrome; PLSG ¼ primary laparoscopic sleeve gastrectomy. * Data are presented as mean ⫾ standard deviation [min–max].
postoperative day 5 after being able to eat mashed foods. The postoperative assessments were conducted by a surgeon in our bariatric team at 1, 3, 6, 9, 12, 18, and 24 months postoperatively and, from the third year on, annually. In an effort to reduce the number of dropouts, patients who failed to attend their appointments were contacted by telephone and invited to reschedule the follow-up. Those who refused to attend the visit were asked to answer a telephone questionnaire on their weight loss, clinical evolution, and complications after LSG. Statistical analysis Continuous demographic and outcome variables were expressed as mean ⫾ standard deviation and range; categorical variables were reported as number and percentage. Data analysis was performed on available patients at each follow-up time point. Fisher’s exact test and χ2 test were used to investigate relationships between categorical variables. Comparison of continuous outcomes between the groups was carried out by means of nonparametric unpaired test (i.e., Wilcoxon test). A 2-sided P value o.05 was considered to be significant. Statistical analysis was performed using SAS JMP 10.0 software (SAS Institute Inc, Cary, NC), and graphs were drawn using GraphPad Prism Version 6.01. Results
duration were significantly lower in the PLSG group than the CLSG group (P o .05). The mean number of co-morbidities per patient was 1.1 ⫾ 1.1 (0–5] and included type 2 diabetes in 99 patients (14.1%), dyslipidemia in 118 (16.8%), hypertension in 183 (26.1%), obstructive sleep apnea syndrome in 265 (37.8%), and joint disease in 102 (14.5%). The prevalence of these co-morbidities was comparable between groups (Table 1). The numbers of available patients at each time point (i.e., patients with ongoing follow-up and not converted to another bariatric procedure) and eligible patients are presented in Fig. 1. The proportion of patients lost to follow-up was comparable between PLSG and CLSG groups at all postoperative (PO) time points (PO 2 yr: 1% versus 0%, P ¼ 1; 3 yr: 2.6% versus 2.1%, P ¼ 1; 4 yr: 4% versus 1.4%, P ¼ .48; 5 yr: 6.1% versus 2.3%, P ¼ .47; 6 yr: 21.2% versus 28%, P ¼ .58; 7 yr: 46.7% versus 83.3%, P ¼ .18). In the CLSG group the main reason for conversion was insufficient weight loss in the presence of a functioning gastric band (n ¼ 60; 60%). Intractable side effects and/or band-related complications were present in another 40 (40%) cases. All procedures were performed laparoscopically except in 2 patients, 1 in each group (.3%), who required a conversion to open surgery because of multiple adhesions. The mean delay between gastric band removal and conversion to LSG was 16.8 ⫾ 18.3 months (2–123 mo). The average operative duration and length of stay were 102 ⫾ 21.6 minutes (53–180 min) and 6.2 ⫾ 6.9 days (1–90 d) and were comparable between groups (Table 1).
Patient characteristics During the period considered, 701 patients, including 601 PLSG and 100 CLSG, underwent a LSG. The baseline characteristics of each patient group are presented in Table 1. Mean preoperative age, BMI, and operative
Complications Postoperative morbidity outcomes after PLSG and CLSG are presented in Table 2. There was no in-hospital mortality
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Fig. 1. Flowchart of eligible and available patients included in the study at each follow-up time. * Total/PLSG/CLSG n; § total/PLSG/CLSG n(%). T0 ¼ preoperative period; CLSG ¼ conversion to LSG after failed LAGB; PLSG ¼ primary laparoscopic sleeve gastrectomy.
in either group. The incidence of early and late complications was 7.4% (n ¼ 52) and 3.1% (n ¼ 22), respectively, with no difference between groups. In addition, the occurrence of postoperative leaks (overall: n ¼ 26; 3.8%), hemorrhage (overall: n ¼ 7; 1%), and stenosis (overall: n ¼ 14; 2%) were comparable between groups (P ¼ ns) (Table 2). Nine of the 24 leaks (37.5%) in the primary group and all (n ¼ 2) of the leaks that occurred in the conversion group were initially treated by laparoscopic drainage and lavage of the abdominal cavity. The remaining 15 leaks (62.5%) that occurred in the PLSG group were treated conservatively with parenteral nutrition, antibiotic therapy, and, in 3 of them, with the placement of an endoluminal stent. One patient in the PLSG and 1 in the CLSG group (.3%) required a conversion to total gastrectomy for chronic leak .9 and 1.9 years, respectively, after LSG. Postoperative bleeding occurred in 7 patients (1.1%). Conservative medical treatment was possible in only 1 of 6 patients in the primary group, whereas an exploratory laparoscopy was necessary in the other patients. Fourteen patients (2%) experienced a stenosis that was successfully treated by endoscopic dilation except in 2 refractory cases that required conversion into RYGB at .6 and 4.5 years after surgery. Seven patients in the PLSG group (1.1%) had postoperative neurologic complications (paresthesia of upper and lower extremities, dysesthesia, and in 2 cases, symptoms consistent with Wernicke encephalopathy) with a mean delay of 4.6 ⫾ 3.4 months (3–12 mo) after LSG. They all had rapid weight loss within the first few months of the surgery with a mean %EWL reaching 63.8 ⫾ 6.9%. None of the patients in the CLSG group experienced this type of late complication. Six patients (1.1%) in the PLSG group and 4 (4%) in the CLSG group underwent a
conversion into RYGB for insufficient weight loss or weight regain with a mean delay of 3.7 ⫾ 1.4 years (2–6 yr) after LSG (P ¼ .019). Weight loss The average follow-up for CLSG patients was 4.3 ⫾ 1.6 years (.9–8.2 yr), whereas the average follow-up for patients in the PLSG group was 3.6 ⫾ 1.4 years (.6–8.1 yr) (P o .0002). In the CLSG the mean BMI at the time of band removal and conversion to sleeve gastrectomy were, respectively, 42.3 ⫾ 9 kg/m2 and 46 ⫾ 8.8 kg/m2 (P ¼ .004). Weight loss outcomes for PLSG and CLSG groups (i.e., BMI, %EWL, and %EBL) are presented in Fig. 2. The %EWL and %EBL rates were significantly higher in the primary group than after revisional LSG at 1, 2, 3, 4, 5 (P o .0001), and 6 years postoperatively (P o .05) (Figs. 2B and 2C). These differences were observed from Table 2 Complications recorded in PLSG and CLSG groups.
Overall morbidity, n (%) Early morbidity (o30 POD), n (%) Late morbidity (430 POD), n (%) Hemorrhage, n (%) Leakage, n (%) Stenosis, n (%)
PLSG (n ¼ 601)
CLSG (n ¼ 100)
P
68 (11.3) 48 (8)
6 (6) 4 (4)
.15 .21
20 (3.3)
2 (2)
.48
6 (1) 24 (4) 11 (1.8)
1 (1) 2 (2) 3 (3)
1 .56 .43
CLSG ¼ conversion laparoscopic sleeve gastrectomy; PLSG ¼ primary laparoscopic sleeve gastrectomy; POD ¼ postoperative days.
341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 F2376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395
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5
Fig. 2. Weight outcomes at 1, 2, 3, 4, 5, and 6 postoperative years in CLSG and PLSG groups. (A) Body mass index (BMI); (B) percentage of excess weight loss (%EWL); (C) percentage of excess BMI loss (%EBL). * Mean ⫾ SD [min–max]; # CLSG versus PLSG. CLSG ¼ conversion to LSG after failed LAGB; PLSG ¼ primary laparoscopic sleeve gastrectomy.
postoperative month 3 onward (%EWL PLSG: 35 ⫾ 13.2% [0–81.5%] versus CLSG: 22.6 ⫾ 9.7% [0–46.8%]; %EBL: PLSG: 40.2 ⫾ 15.8% [0–94.7%] versus CLSG:
25.9 ⫾ 11.2% [0–54.5%]). Furthermore, patients in the conversion group had a rate of failure (%EWL o50%) exceeding 40% at each follow-up interval, which was
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Table 3 Failure rate (%EWL o50%) PLSG and CLSG groups (calculated in available population) Delay after surgery, mo
PLSG*
12 24 36 48 60 72
104/600 70/498 48/318 37/179 26/80 5/15
(17.3) (14.1) (15.1) (20.7) (32.5) (33.3)
CLSG*
P
50/99 41/95 34/69 26/42 17/25 5/6
o.0001 o.0001 o.0001 o.0001 .0023 .06
(50.5) (43.1) (49.3) (61.9) (68) (83)
CLSG ¼ conversion laparoscopic sleeve gastrectomy; %EWL ¼ percentage of excess weight loss; PLSG ¼ primary laparoscopic sleeve gastrectomy. * Data are presented as n/N (%).
significantly higher than in the primary group during the first 60 postoperative months. At 6 postoperative years, this difference was no longer significant (Table 3). Additionally, we separately analyzed the weight loss results of patients who underwent band removal for insufficient weight loss (n ¼ 60) and patients who experienced band-related complications and/or intractable symptoms (n ¼ 40) (Table 4). The mean BMI did not differ between the 2 groups before gastric banding (47 ⫾ 8 kg/m2 versus 45 ⫾ 6.7 kg/m2; P ¼ .15). On the other hand, the mean BMI recorded before conversion to LSG was significantly lower in the group with band complications (P ¼ .0019), having a better response to gastric banding. The difference in terms of %EWL and %EBL between the 2 groups did not reach statistical significance at any other time point during follow-up. However, despite a lack of significance, better outcomes were identified in CLSG patients who experienced band complications (Table 4). Discussion In 2006, Suter et al. [18] warned the scientific community that if the early results of LAGB reported in their study were confirmed in the long term, thousands of patients would require reoperations because of severe complications and/or insufficient weight loss. Ten years later, this warning was justified by several long-term LAGB studies and by the increasing number of conversion procedures in bariatric practice [5–7,18,19]. Among the different surgical approaches for dealing with failed gastric banding, LSG has gained momentum as an alternative to more complex malabsorptive procedures such as LRYGB or biliopancreatic diversion. In our university hospital we started to perform conversion of failed LAGB into LSG in 2007, and in a previous report where we compared LSG and LRYGB as conversion surgery we found an excellent 65% of %EWL at 3 postoperative years [20]. Unfortunately, this result was not confirmed in the present study with a larger sample of patients and a longer follow-up (51% and 37% at 3 and 5 postoperative yr, respectively).
LSG as a conversion procedure in this study produced weight loss results that were significantly inferior to the primary procedure at every stage of follow-up. After primary LSG, we recorded a %EWL of 71.6% and 63.5%, respectively, at postoperative years 2 and 5, which is in keeping with the literature [16,21]. On the other hand, at the same follow-up times, the average %EWL in the conversion group was 52.6% and 37%, respectively. Published data on the latter group are contradictory and
Table 4 Postsurgical weight loss in LAGB to SG patients according to LAGB failure
Baseline* Age, yr† Sex ratio, M/F‡ Weight, kg† BMI, kg/m² PO 3 mo* BMI, kg/m²† %EWL† %EBL† PO 6 mo* BMI, kg/m²† %EWL† %EBL† PO 12 mo* BMI, kg/m²† %EWL† %EBL† PO 24 mo* BMI, kg/m²† %EWL† %EBL† PO 36 mo* BMI, kg/m²† %EWL† %EBL† PO 48 mo* BMI, kg/m²† %EWL† %EBL† PO 60 mo* BMI, kg/m² %EWL %EBL PO 72 mo† BMI, kg/m² %EWL %EBL
Band-related complication (n ¼ 40)
Insufficient weight lo (n ¼ 60)
n ¼ 40 40.7 ⫾ 10.9 7 (17.5)/33 (82.5) 115.5 ⫾ 21 43.1 ⫾ 8.4 n ¼ 40 38.1 ⫾ 6.1 23.8 ⫾ 9 27.7 ⫾ 10.6 n ¼ 40 35.3 ⫾ 6 37.6 ⫾ 11.4 43.7 ⫾ 13 n ¼ 39 32.9 ⫾ 6 49.8 ⫾ 13.9 58.1 ⫾ 16.2 n ¼ 39 31.7 ⫾ 6.3 56.8 ⫾ 18.7 65.5 ⫾ 22 n ¼ 30 32.5 ⫾ 7.7 54 ⫾ 21.3 62.8 ⫾ 25.1 n ¼ 18 35.1 ⫾ 9.1 45.3 ⫾ 21.2 51.8 ⫾ 23.4 n ¼ 14 35.8 ⫾ 9.7 42.2 ⫾ 21.6 52.1 ⫾ 20 n¼3 35.1 ⫾ 8.4 37.1 ⫾ 40.1 41.7 ⫾ 44.3
n ¼ 60 41.3 ⫾ 10.5 8 (13.3)/52 (86.7) 129.9 ⫾ 29.4 47.9 ⫾ 8.5 n ¼ 60 42.6 ⫾ 8 21.8 ⫾ 10.2 24.7 ⫾ 11.6 n ¼ 60 39.3 ⫾ 7.7 35.3 ⫾ 13.1 40 ⫾ 15.3 n ¼ 60 36.1 ⫾ 7.1 47.6 ⫾ 17 53.8 ⫾ 19.5 n ¼ 56 35.3 ⫾ 6.5 50.5 ⫾ 19 56.4 ⫾ 21.5 n ¼ 39 36 ⫾ 6.3 49 ⫾ 18 55.3 ⫾ 20.6 n ¼ 24 38 ⫾ 6.6 42 ⫾ 23.6 51.7 ⫾ 36.5 n ¼ 11 42.2 ⫾ 4.6 30.4 ⫾ 18.7 33.2 ⫾ 20.5 n¼3 40.4 ⫾ 4.3 22.5 ⫾ 13 24.8 ⫾ 14.1
P
.82 .58 .0023 .0019 .0016 .19 .1 .004 .32 .18 .005 .31 .16 .002 .14 .06 .01 .38 .24 .05 .74 .74 .007 .22 .07 .27 .83 .83
BMI ¼ body mass index; CLSG ¼ conversion laparoscopic sleeve gastrectomy; %EBL ¼ percentage of excess BMI loss; %EWL ¼ percentage of excess weight loss; LABG ¼ laparoscopic gastric banding; PLSG ¼ primary laparoscopic sleeve gastrectomy; PO ¼ postoperative; SG ¼ sleeve gastrectomy. * Number of available patients at each follow-up time point. † Data are presented as mean ⫾ standard deviation. ‡ Data are presented as n (%).
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indicate weight loss figures varying over a wide range. Marin-Perez et al. [22], in their retrospective study comparing LRYGB and LSG as conversion procedures after failed LAGB, recorded only 28% of %EWL at 24 months in the LSG group. Rebibo et al. [23] reported 53% of %EWL at 2 years after conversion to LSG with no difference from front-line LSG. On the other hand, in the 2 largest series of CLSG published to date, Iannelli et al. [24] and Alqahtani et al. [25] recorded an impressive 70% and 75% of %EWL, respectively, at 5 postoperative years [16]. A significant difference in terms of weight loss was also present for the first 5 postoperative years when we assessed the rate of failure, with only a trend at postoperative year 6 (P ¼ .06), probably because of a lack of power. Although it is very difficult to define success and failure in bariatric surgery, %EWL as an outcome measure is widely accepted in the literature. As suggested by other authors, we considered a cutoff point of 50% of %EWL as the threshold for success after our gastric sleeve procedures [16,22,26]. As a result, 440% of patients had failure after conversion of LAGB to LSG during followup. Thus, the rate of patients who needed an additional procedure because of insufficient weight loss or weight regain was significantly higher in the CLSG group (4% versus 1.1%). The difference in weight loss results between the conversion group and primary group is difficult to explain. The 2 patient populations were comparable in terms of preoperative co-morbidities and demographic parameters other than their age and BMI at the time of LSG. Patients in the conversion group had undergone at least 2 previous surgeries (LAGB and band removal), and consequently, they were on average older than those in the primary group. This difference was probably not clinically important because, as reported in several retrospective studies, LSG is also effective in elderly patients [27,28]. Likewise, preoperative BMI presumably played a marginal role in determining the difference in weight loss outcomes between the 2 groups. Published data concerning this matter are once again contradictory. Uffort et al. [29] assessed LSG in super-obese and non-super-obese patients and found a comparable rate of co-morbidity resolution and weight loss results in the 2 groups of patients. In contrast, in a recent retrospective study that investigated the indications for conversion of LSG to RYGB, Ianelli et al. [24] found that super-obese patients had a higher risk of weight loss failure compared with non–super-obese patients. All the LSG, regardless of whether they were primary or secondary, were performed in a standardized way, calibrated on a 36F orogastric tube, without lateral traction during the stomach transection, and performed by 2 skilled surgeons. In addition, conversion procedures were carried out in 2 stages: sleeve gastrectomy was performed several months after band ablation. The rationale for this strategy
7
was to restore the original gastric anatomy and to reduce the scar tissue in the upper portion of the stomach before performing the LSG. In other words, when performing the conversion procedure, surgeons were faced with almost the same operative conditions as during a primary surgery. Therefore, the difference in weight loss between the 2 groups cannot be justified by a more prudent intraoperative approach and less extensive gastric resection in patients with previous gastric banding. It is likely that conversion patients are more at risk for failure because they have already experienced a restrictive procedure and so they have devised an eating strategy to counteract the consequent alimentary discomfort after this kind of surgery. This possibility was supported by the analysis of subgroups that underwent band ablation. Patients who did not respond to gastric banding (nonresponders) were differentiated from patients who, after an initial response to the alimentary restriction produced by the band, experienced some complications that finally led to band removal. This second group had a significantly lower BMI at the time of conversion, and this difference was maintained throughout the entire follow-up period. Similarly, the %EWL and %EBL were higher than in the nonresponder patients, especially up to postoperative year 6. According to these results, we believe that as a conversion procedure LSG should not be offered indiscriminately to all patients who experience a banding failure; nonresponder patients would probably experience greater benefit from conversion into a gastric bypass or biliopancreatic diversion. In the last few years, most of the studies regarding LSG as a conversion procedure after failed LAGB have been directed at understanding whether it is better to perform the conversion in 2 steps or concomitantly with band removal, to decrease postoperative risks. Some authors found that the 2-step approach was better tolerated, whereas others found no significant increase in postoperative complications with the 1-step approach [16,23,25,30,31]. In the present study, all of the conversion procedures were performed in 2 steps. The lack of a control group of patients undergoing concomitant band removal and conversion prevents us from resolving the issue regarding the timing of LSG conversion. Based on our data, the only conclusion we can draw is that when performing the conversion a few months after band removal there was no evidence of significant differences in postoperative complications compared with the front-line sleeve. In particular, the Achilles heel of the LSG, namely the leak alongside the staple line, was absolutely comparable between the 2 groups and consistent with previously published data in both cases [32]. Similarly, sleeve stenosis, which is the most common late complication after LSG, had no difference between groups. These data confirm that LSG as a conversion procedure is a well-tolerated procedure in the short and long term.
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This study presents several limitations. The most obvious are its retrospective nature and the small sample of patients. At postoperative year 6, only 5.3% and 13% of the patients in the primary and conversion group were eligible. Another limitation is the rate of follow-up. Although to our knowledge this is the first study regarding a population of patients undergoing conversion to LSG with a 46% follow-up rate at 6 postoperative years, a 450% dropout percentage remains extensive and could potentially alter the global judgment on the treatment in the long term. Conclusion LSG as a conversion procedure after gastric banding failure is a well-tolerated procedure with postoperative complications comparable to primary LSG when performed in 2 steps. The conversion of a failed LAGB into LSG did not produce weight loss results that were as good as those after PLSG, and about 40% of patients in the long term potentially needed a third operation because of insufficient weight loss. To obtain better results, patients classified as nonresponders to LAGB probably should undergo a more intensive behavioral and psychological program before being scheduled for a conversion to LSG.
[10]
[11]
[12]
[13]
[14]
[15]
[16]
[17] [18]
Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article.
[19]
References
[20]
[1] Buchwald H, Williams SE. Bariatric surgery worldwide 2003. Obes Surg 2004;14(9):1157–64. [2] Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg 2009;19(12):1605–11. [3] O’Brien PE, McPhail T, Chaston TB, Dixon JB. Systematic review of medium-term weight loss after bariatric operations. Obes Surg 2006;16(8):1032–40. [4] Victorzon M, Tolonen P. Intermediate results following laparoscopic adjustable gastric banding for morbid obesity. Dig Surg 2002;19 (5):354–7; discussion 358. [5] Camerini G, Adami G, Marinari GM, et al. Thirteen years of followup in patients with adjustable silicone gastric banding for obesity: weight loss and constant rate of late specific complications. Obes Surg 2004;14(10):1343–8. [6] Scozzari G, Farinella E, Bonnet G, Toppino M, Morino M. Laparoscopic adjustable silicone gastric banding vs laparoscopic vertical banded gastroplasty in morbidly obese patients: long-term results of a prospective randomized controlled clinical trial. Obes Surg 2009;19(8):1108–15. [7] Aarts EO, Dogan K, Koehestanie P, Aufenacker TJ, Janssen IMC, Berends FJ. Long-term results after laparoscopic adjustable gastric banding: a mean fourteen year follow-up study. Surg Obes Relat Dis 2014;10(4):633–40. [8] Gagner M, Gumbs AA. Gastric banding: conversion to sleeve, bypass, or DS. Surg Endosc 2007;21(11):1931–5. [9] Weber M, Muller MK, Michel JM, et al. Laparoscopic Roux-en-Y gastric bypass, but not rebanding, should be proposed as rescue
[21]
[22]
[23]
[24]
[25]
[26]
[27]
procedure for patients with failed laparoscopic gastric banding. Ann Surg 2003;238(6):827–33; discussion 833–4. Müller MK, Attigah N, Wildi S, et al. High secondary failure rate of rebanding after failed gastric banding. Surg Endosc 2008;22 (2):448–53. Ardestani A, Lautz DB, Tavakkolizadeh A. Band revision versus Roux-en-Y gastric bypass conversion as salvage operation after laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2011;7 (1):33–7. Perathoner A, Zitt M, Lanthaler M, Pratschke M, Biebl M, Mittermair R. Long-term follow-up evaluation of revisional gastric bypass after failed adjustable gastric banding. Surg Endosc 2013;27 (11):4305–12. Moon RC, Teixeira AF, Jaward MA. Conversion of failed laparoscopic gastric banding: sleeve gastrectomy or Roux-en-Y gastric bypass? Surg Obes Rel Dis 2013;9(6):901–7. Yazbek T, Safa N, Denis R, Atlas H, Garneau PY. Laparoscopic sleeve gastrectomy (LSG)-A good bariatric option for failed laparoscopic adjustable gastric banding (LAGB): a review of 90 patients. Obes Surg 2013;23(3):300–5. Berende CAS, de Zoete JP, Smulders JF, Nienhuijs SW. Laparoscopic sleeve gastrectomy feasible for bariatric revision surgery. Obes Surg 2012;22(2):330–4. Noel P, Schneck AS, Nedelcu M, et al. Laparoscopic sleeve gastrectomy as a revisional procedure for failed gastric banding: lessons from 300 consecutive cases. Surg Obes Rel Dis 2014;10 (6):1116–22. Reinhold RB. Critical analysis of long term weight loss following gastric bypass. Surg Gynecol Obstet 1982;155(3):385–94. Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg 2006;16 (7):829–35. Angrisani L, Santonicola A, Iovino P, Formisano G, Buchwald H, Scopinaro N. Bariatric Surgery Worldwide 2013. Obes Surg 2015;25 (10):1822–32. Carandina S, Maldonado PS, Tabbara M, et al. Two-step conversion surgery after failed laparoscopic adjustable gastric banding. Comparison between laparoscopic Roux-en-Y gastric bypass and laparoscopic gastric sleeve. Surg Obes Relat Dis 2014;10 (6):1085–91. Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg 2010;252 (2):319–24. Marin-Perez P, Betancourt A, Lamota M, Lo Menze E, Szomstein S, Rosenthal R. Outcomes after laparoscopic conversion of failed adjustable gastric banding to sleeve gastrectomy or Roux-en-Y gastric bypass. BJS 2014;101(3):254–60. Rebibo L, Mensah E, Verhaeghe P, et al. Simultaneous gastric band removal and sleeve gastrectomy: a comparison with front-line sleeve gastrectomy. Obes Surg 2012;22(9):1420–6. Iannelli A, Debs T, Martini F, Benichou B, Ben Amor I, Gugenheim J. Laparoscopic conversion of sleeve gastrectomy to Roux-en-Y gastric bypass: indications and preliminary results. Surg Obes Relat Dis 2016;12(8):1533–8. Alqahtani AR, Elahmedi MO, Al Qahtani AR, Yousefan A, Al-Zuhair AR. 5-year outcomes of 1-stage gastric band removal and sleeve gastrectomy. Surg Obes Relat Dis 2016;12(10):1769–77. Spivak H, Abdelmelek MF, Beltran OR, Ng AW, Kitahama S. Longterm outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in the United States. Surg Endosc 2012;26(7):1909–19. Burchett MA, McKenna DT, Selzer DJ, Choi JH, Mattar SG. Laparoscopic sleeve gastrectomy is safe and effective in elderly patients: a comparative analysis. Obes Surg 2015;25(2):222–8.
781 782 783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835
Laparoscopic Sleeve Gastrectomy After Failed Gastric Banding / Surgery for Obesity and Related Diseases ] (2017) 00–00
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[28] Keren D, Matter I, Rainis T. Sleeve gastrectomy in different age groups: a comparative study of 5-year outcomes. Obes Surg 2016;26(2):289–95. [29] Uffort E, Nease B, Canterbury T. Laparoscopic sleeve gastrectomy with comparable weight loss in all obese groups: a VA hospital experience. Am Surg 2013;79(7):739–42. [30] Silecchia G, Rizzello M, De Angelis F, et al. Laparoscopic sleeve gastrectomy as a revisional procedure for failed laparoscopic gastric banding with a “2-step approach”: a multicenter study. Surg Obes Rel Dis 2014;10(4):626–31.
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[31] Obeid NR, Schwack BF, Kurian MS, Ren-Fielding CJ, Fielding GA. Single-stage versus 2-stage sleeve gastrectomy as a conversion after failed adjustable gastric banding: 30-day outcomes. Surg Endosc 2014;28(11):3186–92. [32] Rosenthal RJ; International Sleeve Gastrectomy Expert Panel, Diaz AA, et al. International sleeve gastrectomy expert panel consensus statement: best practice guidelines based on experience of 412,000 cases. Surg Obes Relat Dis 2012;8 (1):8–19.
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