Five-year results of laparoscopic sleeve gastrectomy for the treatment of severe obesity

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1 DOI /s and Other Interventional Techniques Five-year results of laparoscopic sleeve gastrectomy for the treatment of severe obesity David Nocca 1,2 Marcelo Loureiro 1,2,3 El Mehdi Skalli 2 Marius Nedelcu 2 Audrey Jaussent 2 Melanie Deloze 2 Patrick Lefebvre 1,2 Jean Michel Fabre 1,2 Received: 21 July 2016 / Accepted: 12 November 2016 Springer Science+Business Media New York 2016 Abstract Background Since 2011, the most used bariatric technique in France has been the sleeve gastrectomy. There are still few studies exploring the medium and long-term results of this technique. Objective To describe medium long-term (5 years) results of a cohort of CHU Montpellier experience in sleeve gastrectomy for morbid obesity. Methods All patients that underwent laparoscopic sleeve gastrectomy (LSG) from January 2005 to June 2013 were included in this study. & David Nocca davidnocca71@gmail.com Marcelo Loureiro mpailoureiro@gmail.com El Mehdi Skalli e-skalli@chu-montpellier.fr Marius Nedelcu m-nedelcu@chu-montpellier.fr Audrey Jaussent a-jaussent@chu-montpellier.fr Melanie Deloze m-deloze@chu-montpellier.fr Patrick Lefebvre p-lefebvre@chu-montpellier.fr Jean Michel Fabre jm-fabre@chu-montpellier.fr Université Montpellier 1, Montpellier, France CHU de Montpellier, 80 Avenue Augustin Fliche, Montpellier, France Mestrado em Biotecnologia, Universidade Positivo, Curitiba, Brazil Results A total of 1050 patients were operated % were women. The mean preoperative BMI was kg/ m 2 (±7.71). A total of 183 patients (18.5%) were superobese (BMI [ 50 kg/m 2 ). LSG was proposed as primary procedure, and also after failure of adjustable gastric banding in 169 patients (16.9%) or after vertical banded gastroplasty in 7 cases (0.7%). There were 38 postoperative gastric fistulas (3.8%) and 3 of them required some kind of bypass to be definitively treated. There were also 34 hemorrhages (3.4%) of which 21 were reoperated for hemostasis. Two gastric stenoses at the angulus (0.2%) were managed with dilation or RYGB. Overall reoperative rate was 6.8%. One patient died of pulmonary embolism. Most common late complication was GERD (39.1%). After 3, 4 and 5 years of LSG, the average of %EBL was, respectively, 75.95% (±29.16) (382 patients), 73.23% (±31.08) (222 patients) and 69.26% (±30.86) (144 patients). The success rate at 5 years was 65.97% (95 patients). The improvement or remission of comorbidities was found, respectively, in 88.4 and 57.2% of diabetic patients; 76.9 and 19.2% for hypertensive patients and 98 and 85% for patients with sleep apnea syndrome. Conclusion LSG is a bariatric surgery technique that presents a very good risk/benefit ratio. Five-year results are very convincing. GERD is the main long-term complication. Keywords Sleeve gastrectomy Bariatric surgery Laparoscopy Hemorrhage Gastroesophageal reflux Leak The surgical management of patients with morbid obesity has been consensual for the past decades. The increasing prevalence of obesity associated with low efficiency of

2 long-term medical treatment is the cause of this medical and social phenomenon. Today, two main types of bariatric surgery interventions through laparoscopy are performed: Those based exclusively on gastric restriction: gastric banding and sleeve gastrectomy. Those associated with intestinal malabsorption: biliopancreatic diversion with or without duodenal switch and gastric bypass. The choice of surgical technique is made by a consensus between the multidisciplinary team and the patient. More than 47,500 operations were carried out in France in 2014 (PMSI data) [1]. Since 2011, the most used technique in France has been the sleeve gastrectomy (about 27,500 cases in 2014). Our team has been performing bariatric surgery since 1996, and it was the first one to evaluate this technique in Europe as part of a prospective multicentric study [2]. The medium long-term (5 years) cohort of CHU Montpellier experience is analyzed in this article. Material and methods After institutional review board approval, we retrospectively reviewed a prospectively collected database of all patients who underwent LSG from January 2005 to June 2013 at CHU of Montpellier. Given the observational design of the study, the French law did not require individual informed consent. Inclusion criteria All patients that underwent a multidisciplinary evaluation and were selected for LSG based on the recommendations of the Haute Autorité de Santé 2009 [3] were included. Clear information was given to patients who were enrolled in a prospective database evaluating weight loss, changes in morbid obesity comorbidities, as well as the morbidity and mortality of the operation at 1, 6, 12, 24, 36, 48 and 60 months. Absolute contraindications Patients with portal hypertension and with esophageal or gastric varices were not eligible for a sleeve-type surgery. A laparoscopic gastric bypass (LGB) was proposed as first line for patients with severe gastroesophageal reflux (GERD) or Barrett s esophagus. Surgical technique The technique of LSG was standardized in 2005 by different surgeons from our team. The first step is to release the gastrocolic ligament in contact with the gastric wall in order to get access to the lesser sac. The dissection begins at about 5 6 cm from the pylorus, and it continues with the ultrasonic dissector toward the angle of His, until the complete release of the greater curvature of the stomach is achieved. A 36-French Faucher tube is then inserted in the stomach and positioned against the lesser curvature aiming to allow the realization of a narrow gastric sleeve. The gastric vertical section begins at the end of Faucher tube over the wall of the gastric antrum (about 5 6 cm pylorus). It creates a path parallel to the lesser curvature, in contact with the calibration tube. This section requires an appropriate staple height according to the thickness of the gastric wall. At the level of the gastric fundus, the stomach wall is significantly thinner, which indicates the use of a different staple height. After stapling, hemostasis was achieved by bipolar coagulation, titanium clips application or by running absorbable sutures. Integrity of the gastric pouch is checked by injection of methylene blue through the gastric tube. A 16-mm caliber silicon drain is left in contact with the stomach. All patients have an intraoperative antibiotic prophylaxis and prevention of venous thrombosis by the regular use of low molecular weight heparin during hospitalization. Since 2012, intermittent compression systems of the lower limbs have been routinely used during surgery to prevent thromboembolic events. Postoperative management A radiological control was performed with a contrast study two days after the procedure to ensure the absence of fistula and satisfactory passage through the gastric pouch. The normality of the radiological control allowed the recovery of a liquid diet on the second postoperative day. Since 2013, this systematic radiological control has been replaced by a selective CT scan with oral contrast in case of clinical suspicion (tachycardia, persistent abdominal pain, low blood pressure, dyspnea) or laboratory suspected data (decreased blood hemoglobin, PCR increase). Statistical analysis The patients lost for follow-up were either contacted for consultation or investigated by telephone. Quantitative variables were described with means and standard deviations (SD) and median with range. Their distributions were tested with the Shapiro Wilk test. Qualitative variables were described with frequencies and percentages. Results From January 2005 to June 2013, 1050 patients (72.86% women) underwent LSG performed by 5 experts that perform laparoscopic and bariatric surgery.

3 LSG was proposed either as a restrictive primary operation in 824 cases (82.4%) or after failure of other techniques [adjustable gastric banding in 169 patients (16.9%)], [vertical banded gastroplasty in 7 cases (0.7%)]. The mean age was 42.7 years (±12.7). The mean preoperative BMI was kg/m 2 (±7.71). A total of 183 patients (18.5%) were super-obese (i.e., BMI [ 50 kg/m 2 ). The main comorbidities related to obesity were represented by the following: type 2 diabetes (n = 183, 18.5%) with 22.4% of those patients (n = 35) under treatment with insulin therapy and 77.6% using oral anti diabetic; hypertension (n = 309, 33.1%); sleep apnea syndrome (n = 405, 47.1%); and GERD (n = 167; 21.27%). Baseline characteristics are presented in Table 1. The laparoscopic surgery was used in 998 cases. No conversion to laparotomy was necessary among these patients. Other 52 patients were planned open laparotomy from the start, specially because of previous abdominal surgery. The majority of them were in the beginning of our experience. Intraoperative complications (1.6%) were represented by: failure of stapling line (0.3%), stapling of nasogastric tube (0.1%), minor lesions to the liver (1%) or to the spleen (0.2%), which did not require splenectomy. In three cases, sleeve gastrectomy could not be performed: One due to a portal hypertension caused by a mixed cirrhosis (alcohol? NASH syndrome) undiagnosed preoperatively (umbilical vein diameter of 5 cm); another because of a giant left lobe of the liver, and the other was a case of very important adhesion in the peri-hiatal region. The average hospitalization time was 5.3 days (±4.6) ( ). The perioperative mortality rate was 0.1%, represented by a pulmonary embolism that happened during the management of a staple line bleeding. Table 1 Baseline characteristics Characteristic n = 1050 Female/male, n (%) (72.86%)/19 (27.14%) Mean ± SD age (range), years 42.7 ± 12.7 Mean ± SD pre op BMI (range), kg/m ± 7.7 BMI [ 50 kg/m 2, n (%) 183 (18.5%) Hypertension, n (%) 309 (33.1%) Obstructive sleep apnea, n (%) 405 (47.1%) Diabetes, n (%) 183 (18.5%) GERD, n (%) 167 (21.3%) Primary sleeve, n (%) 824 (82.4%) Revisional After band, n (%) 169 (16.9%) After VBG, n (%) 7 (0.7%) GERD gastroesophageal reflux disease, VBG vertical banded gastroplasty Reoperative rate was 6.8%. Indications for reoperation were as follows: 38 gastric fistulas (3.8%) that were treated by peritoneal lavage, drainage and antibiotic therapy (3%) or endoscopic treatment and antibiotic therapy (0.8%). Three of those leaks required further fistulo-jejunostomy: One was associated with a pulmonary surgery, another was operated again, and the other was an esophagojejunostomy. 2 gastric stenosis at the angulus (0.2%) that required endoscopic dilatation in one case and a conversion to gastric bypass in the other case; 34 hemorrhages (3.4%) treated through 21 reoperations for hemostasis (18 cases of bleeding on staple line and 3 cases of trocar site bleeding); 4 trocar hernias (0.4%); There were also other postoperative complications represented by the following: bile reflux caused by Gayet Wernicke syndrome [2 cases(0.2%)], and treated with Ulcar (Sucralfate) 1 sachet X 3/day. portal vein thrombosis treated with Heparin [3 cases (0.3%)]; gastroesophageal reflux disease GERD (39.1%). Although some patients had GERD symptoms before the procedure, they reported that such symptoms disappeared in the postoperative period (5. 8%); biliary pain [36 patients (3.6%)] requiring cholecystectomy; acute pancreatitis bile (3 patients(0.3%). a major depression with suicide attempt (0.01%). Peri and postoperative data and complications are summarized in Table 2. From a total of 175 patients that had completed 5 years of surgery, 144 (82.3%) were available for follow-up. The data of percentage of excess BMI loss (%EBL) are presented in Fig. 1. After 3, 4 and 5 years of treatment, the average %EBL was, respectively, 75.95%, (±29.16) (382 patients), 73.23% (±31.08) (222 patients) and 69.26% (±30.86) (144 patients). The specific analysis of patients with previous gastric banding found that the %EBL at 3, 4 and 5 years was, respectively, 68.86% (±33.87) (72 patients), 63.40% (±35.37) (51 patients), 64.81% (±38.82) (34 patients). Among the super-obese group of patients, the %EBL at 3, 4 and 5 years was, respectively, of 59.23% (±22.18) (82 patients), 59.50% (20.45) (51 patients) and 58.01% (±21.50) (37 patients). The success rate at 5 years according to the index of Reinhold (EWL [ 50%) was 65.97% (95 patients) in the overall cohort; 50% (19 patients) among those who had a

4 Table 2 Peri- and postoperative data Peri- and postoperative data n = 1050 Laparoscopy/laparotomy, n (%) 998 (95%)/52 (5%) Intraoperative complications, n (%) 16 (1.6%) Failure of staple line, n (%) 3 (0.3%) Stapling NG tube, n (%) 1 (0.1%) Minor liver or spleen lesions, n (%) 12 (1.2%) Aborted procedure, n (%) 3 (0.3%) Mean ± SD (range) hospitalization, days 5.3 (±4.6) ( ) Per op mortality, n (%) 1 (0.1%) Reoperations, n (%) 68 (6.8%) Gastric fistula (surgical drainage? ATB), n (%) 30 (3%) Gastric fistula (endoscopic drainage? ATB), n (%) 8 (0.8%) Fistulo-jejunostomy, n (%) 3 (0.3%) Pulmonary resection, n (%) 1 (0.1%) Esophago-jejunostomy, n (%) 1 (0.1%) Hemorrhages (reoperations), n (%) 34 (3.4%) Staple line/trocar site, n (%) 18 (1.8%)/3 (0.3%) Gastric stenosis, n (%) 2 (0.2%) Dilatation/conversion to bypass, n (%) 1 (0.1%)/1 (0.1%) Chronic complications Trocar hernia, n (%) 4 (0.4%) Bile reflux, n(%) 2 (0.2%) Biliary pain, n(%) 36 (3.6%) Pancreatitis, n(%) 3 (0.3%) Portal vein thrombosis, n(%) 3 (0.3%) GERD, n(%) 391 (39.1%) Major depression, n(%) 1 (0.1%) GERD gastroesophageal reflux disease patients) among those with a previous gastric banding and 8.11% in the super-obese group (3 patients). (Figure 2). The improvement or remission of comorbidities data was based on patient s reports about their treatments and was found, respectively, in 88.4% and 57.2% of diabetic patients (mean follow-up of 33 months), 76.9 and 19.2% for hypertensive patients (mean follow-up 38 months), as well as 98 and 85% for patients with sleep apnea syndrome (mean follow-up 38 months). Discussion Fig. 1 Mean percentage of excess body mass index loss (%EBL) at 3, 4 and 5 years after SG in the whole cohort, the group with a previous band and among the super-obese patients previous gastric banding and 54.05% (20 patients) in the super-obese group. The failure rate (EWL \ 25%) was 7.54% (11 patients) in the overall cohort; 15.79% (6 Sleeve gastrectomy was described by Hess and Marceau as a first part of a major surgery: the duodenal switch. The proposal was not only to add a restrictive part in this procedure based on a major phenomenon of food malabsorption, but to reduce the risk of anastomotic ulcer [4, 5]. Nevertheless, aiming to reduce early postoperative complications in super-super-obese patients ([60 kg/m 2 ), some American teams have offered to perform these operations

5 Fig. 2 Mean percentage of excess weight loss(ewl) superior to 50% (success rate) and EWL inferior to 25% (failure rate) at 5 years in the whole cohort and among subgroups of patients with previous band and super-obese in two stages: The first stage consists of performing a sleeve gastrectomy that is more-or-less wide, and the second stage (6 12 months later) would be a LDS or LGBP [6 10]. Interesting results of isolated LSG at short and medium term were responsible for recognizing this operation as a full and definitive procedure [11 14]. This is the latest consensual bariatric technique, which explains that the long-term results ([5 years) do not show significant numbers [15 22]. Despite the low level of evidence of the LSG effectiveness, it was the most practiced bariatric technique in France in 2013 (24,500 cases PMSI data) and in the USA (2013), due to a very interesting risk benefit ratio addressed by our analysis. Effectiveness on weight loss SG technique has evolved tremendously since its description under laparotomy as a part of a DS. As described by our team, the gastric sleeve has become much tighter so to decrease the risk of dilatation of the stomach in the long term. A significant posterior dissection of the gastric fundus has become essential to resect the widest possible part of the fundus. Thus, retrospective analysis to 5 years of our prospective database found very good results, better than the technique of adjustable gastric band and equivalent to those of gastric bypass [23 26]. The %EBL described was 69.26% at 5 years (144 patients). The score of Reinhold was excellent or good in 65.9% of cases, comparing to only 7.54% failure (PEP \ 25%). These results were confirmed by analysis of the recent literature on the subject, represented on Table 3 [16, 17, 19 22, 27, 28]. Long-term EWL vary from 46 to 68%. Analysis of these results must obviously emphasize the small numbers of patients studied for a longer follow-up as well as the fact that during the initial diffusion period of LSG, most surgeons had preferred to offer this for the super-obese patients ([50 kg/m 2 ) or super-super-obese patients ([60 kg/m 2 ), for whom, as shown in our study, LSG has the worst results and the surgical technique is much more difficult to apply. The technique with partial preservation of the antrum, meaning gastric section approximately 6 cm from the pylorus on Faucher tube 36F, carried out by our team, has changed little since Aiming to increase the standardization of gastric resection, since 2011 the calibration has been carried out with a special tube called Midsleeve (MID, Medical Innovation Development, Dardilly, FRANCE) in which there is a cuff that is automatically inflated to 50 cc and positioned in abutment against the pylorus. It also avoids measurement error for the first stapling shot and therefore does not leave a too-wide gastric antrum. LSG is technically less demanding than LRYGB. Therefore, the morbidity and mortality of this procedure are generally low, although some complications described in the literature can be serious [2, 29, 30]. Operative mortality from LSG is classically described between 0.1 and 0.3% (0.1% in our experience, caused by a pulmonary embolism). This rate is lower than the LRYGB (ranging from 02 to 0.5%) [31, 32]. Fistula on the staple line (0 7% in the literature and 3.6% in our experience) is a major postoperative complication that can cause an important delay in operative recovery and hospitalization. This complication should be screened very quickly, based on the classic clinical signs (tachycardia, fever, abdominal and left shoulder pain, dyspnea). Surgical re-exploration is often required to ensure effective drainage. However, if a stage 1 fistula according to the classification of Nedelcu [33] is diagnosed, a medical and endoscopic management can be effective. Endoscopic treatment widely described in the literature [30, 34 38] can be based on the use of stents, clips and internal drains. Stent use has been abandoned by our team because of significant migration rates [38, 39]. The persistence of fistula after 6 months of medical and surgical management should suggest performing a conversion to fistulo-jejunostomy, gastric bypass or esophagus jejunostomy [29, 39]. The occurrence of gastro-bronchial fistula is uncommon (0.4%). The treatment, discussed in a multidisciplinary meeting involving thoracic surgeons, may require a partial pneumonectomy [40]. The gastric stenosis is also rare if the technical prevention rules are respected: mobilization of the calibration tube before every stapling and avoidance of the angulus of the antrum. Hemorrhagic complications at the staple line are common (3.6% in our series) and need to be prevented. The use of biosynthetic buttressing like Seamguard [41, 42], though expensive, is systematically present in our practice.

6 Table 3 SG 5-year weight loss results Article N %EWL %EBL Success rate (%) Bohdjalian [16] 26 NA 55.3 ± 6.9 NA D Hondt [17] ± NA 64.3 Rawlings [19] NA Abbatini [20] ± 23.4 NA NA Boza [21] NA 73.2 Sieber [22] 62 NA 57.4 ± Casella [27] NA 87.1 Gadiot [28] 126 NA 59 ± Present study %EWL percentage of excess weight loss, %EBL percentage of excess BMI loss, NA not available Postoperative morbidity in the long term, including the reoperation rate is very low compared to other bariatric techniques. This is the major advantage of the LSG particularly if we consider the loss of follow-up. Gastroesophageal reflux is the main complication (15 35%) [43, 44]. Treatment with proton pump inhibitor is mostly effective on the control of patients symptoms. Endoscopic surveillance is desirable in the long term for these patients. Otherwise, conversion to LRYGB can be indicated (0.5%) [45]. Limitations This is a retrospective study, with a loss of 17.7% of patients follow-up at 5 years. Even if patients were aware of the need for follow-up, many have canceled or did not show up. Conclusion LSG is a bariatric surgery technique that presents a very good risk/benefit ratio, which explains why it is the most practiced technique worldwide. It is effective in longterm weight loss, especially for BMI \ 50 kg/m 2. Although the surgical technique is less complex than LRYGB, a few technical remark points are important so to avoid postoperative complications (fistula, bleeding on staple line, gastric stenosis) andespeciallytohelpcreating a tighter sleeve aiming to achieve maximum efficiency with time. The medium to long-term morbidity is essentially represented by GERD. It is usually well controlled by medical therapy (PPI) but requires longterm surveillance. Acknowledgements There were no grants from any industry to develop and accomplish this study. Compliance with ethical standards Disclosures Marcelo Loureiro, El Mehdi Skalli, Marius Nedelcu, Melanie Deloze, Patrick Lefebvre and Jean Michel Fabre have no conflicts of interest or financial ties to disclose. David Nocca received honorarium for speaking engagements from Ethicon Endo-Surgery, MSD, Gore and created patents for MID. References 1. Schaaf C, Iannelli A, Gugenheim J (2015) Current state of bariatric surgery in France. E-mem Acad Nat Chir 14(2): (in French) 2. Nocca D, Kraczykowsky B, Bomans B, Noel P, Picot MC, Blanc MC, Seguin De, de Hons C, Millat B, Gagner M, Monnier L, Fabre JM (2008) A prospective multicenter study of 163 sleeve gastrectomies: results at 1 and 2 years. Obes Surg 18: Haute Autorité de Santé (2009) Obesity: report on surgical treatment in adults. HAS, Saint-Denis La Paine (in French) 4. Marceau P, Gould FS, Simard S, Lebel S, Bourque RA, Potvin M, Biron S (1998) Biliopancreatic diversion with duodenal switch. World J Surg 22(9): Hess DS, Hess DW (1998) Biliopancreatic diversion with a duodenal switch. Obes Surg 8(3): Regan JP, Inabmet WB, Gagner M, Pomp A (2003) Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg 13: Nguyen NT, Longoria M, Gelfand DV, Sabio A, Wilson SE (2005) Staged laparoscopic Roux-en-Y: a novel two-stage bariatric operation as an alternative in the super-obese with massively enlarged liver. Obes Surg 15(7): Cottam D, Qureshi FG, Sg Mattar, Sharma S, Hoover S, Bonanomi G et al (2006) Laparoscopic sleeve gastrectomy as an initial weight loss procedure for high risk patients with morbid obesity. Surg Endosc 20(6): Gumbs AA, Gagner M, Dakin G, Pomp A (2007) Sleeve gastrectomy for morbid obesity. Obes Surg 17: Eid GM, Brethauer S, Mattar SG, Titchner RL, Gourash W, Schauer PR (2012) Laparoscopic sleeve gastrectomy for super obese patients: forty-eight percent excess weight loss after 6 8 years with 93% follow-up. Ann Surg 256(2): Moon Han S, Kim WW, Oh JH (2005) Results of laparoscopic sleeve gastrectomy (LSG) at 1 year in morbidly obese Korean patients. Obes Surg 15(10):

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