The Sleeve Bypass Trial: a multicentre randomized controlled trial comparing the long term outcome of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity in terms of excess BMI loss percentage and quality of life

L Ulas Biter, Ralph P M Gadiot, Brechtje A Grotenhuis, Martin Dunkelgrün, Stefanie R van Mil, Hans J J Zengerink, J Frans Smulders, Guido H H Mannaerts, L Ulas Biter, Ralph P M Gadiot, Brechtje A Grotenhuis, Martin Dunkelgrün, Stefanie R van Mil, Hans J J Zengerink, J Frans Smulders, Guido H H Mannaerts

Abstract

Background: Obesity is an increasing disease worldwide. Bariatric surgery is the only effective therapy to induce sufficient long-term weight loss for morbidly obese patients. Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold standard surgical technique. Laparoscopic Sleeve Gastrectomy (LSG) is a new promising bariatric procedure which has the advantage of maintaining an intact gastrointestinal tract. The aim of this study is to evaluate the efficiency of both techniques. Our hypothesis is that LSG has a similar percentage excess BMI loss (%EBMIL) after 5 years compared to LRYGB.

Methods/design: The Sleeve Bypass Trial is a randomized multicentre clinical trial: patients eligible for bariatric surgery are randomized to either LSG or LRYGB. Patients with a body mass index (BMI) ≥ 40 kg/m(2) or BMI 35 kg/m(2) with obesity related comorbidity (T2 DM, sleep apnoea, hypertension) are eligible for randomization. At randomization patients are stratified for centre, sex, T2 DM and BMI ≥ 50 kg/m(2). A total number of 620 patients will be enrolled and equally (1:1) randomized to both treatment arms. Only surgeons experienced in both operation techniques will participate in the Sleeve Bypass trial. The primary endpoint is the 5-year weight loss (%EBMIL) of LSG and LRYGB. Secondary endpoints are resolution of obesity related comorbidity, complications, revision bariatric surgery and quality of life (QOL) defined in various questionnaires.

Discussion: Long-term %EBMIL between the two treatment strategies used to be in favour of LRYGB, but more recent results throughout the world show similar %EBMIL in both techniques. If weight loss is comparable, obesity-related comorbidity and QOL after bariatric procedures should be taken into account when deciding on which surgical technique is to be preferred for certain subgroups in the future.

Trial registration: Dutch Trial Register: NTR 4741.

Keywords: Bariatric surgery; Bypass; Sleeve.

Figures

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Fig. 1
CONSORT flowchart

References

    1. Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW., Jr Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999;15:1097–105. doi: 10.1056/NEJM199910073411501.
    1. Elte JWF, Castro Cabezas M, Vrijland WW, Ruseler CH, Groen M, Mannaerts GHH. Proposal for a multidisciplinary approach to the patient with morbid obesity: the Sint Franciscus Hospital morbid obesity program. Eur J Intern Med. 2008;19:92–8. doi: 10.1016/j.ejim.2007.06.015.
    1. Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, et al. Bariatric surgery versus non-surgical treatment for obesity: a systemic review and meta-analysis of randomised controlled trials. BMJ. 2013;347:15934. doi: 10.1136/bmj.f5934.
    1. James PT, Rigby N, Leach R; International Obesity Task Force. The obesity epidemic, metabolic syndrome and future prevention strategies. Eur J Carddiovasc Prev Rehab. 2004;11:3–8.
    1. Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, et al. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005;142:547–59. doi: 10.7326/0003-4819-142-7-200504050-00013.
    1. Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. NEngl J Med. 2007;357:741–52. doi: 10.1056/NEJMoa066254.
    1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724–37. doi: 10.1001/jama.292.14.1724.
    1. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013;4:427–36. doi: 10.1007/s11695-012-0864-0.
    1. Peterli R, Borbely Y, Kern B, Gass M, Peters T, Thurnheer M, et al. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS) Annals of Surgery. 2013;258(5):690–695. doi: 10.1097/SLA.0b013e3182a67426.
    1. Overs SE, Freeman RA, Zarshenas N, Walton KL, Jorgensen JO. Food tolerance and gastrointestinal quality of life following three bariatric procedures: adjustable gastric banding, Roux-en-Y gastric bypass and sleeve gastrectomy. Obes Surg. 2012;22:536–543. doi: 10.1007/s11695-011-0573-0.
    1. Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg. 2008;247:401–7. doi: 10.1097/SLA.0b013e318156f012.
    1. Kehagias I, Karamanakos SN, Argentou M, Kalfarentzos F. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the management of patients with BMI < 50 kg/m2. Obes Surg. 2011;11:1650–6. doi: 10.1007/s11695-011-0479-x.
    1. Lee WJ, Chong K, Ser KH, Lee YC, Chen SC, Chen JC, et al. Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg. 2011;146:143–8. doi: 10.1001/archsurg.2010.326.
    1. Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366:1567–76. doi: 10.1056/NEJMoa1200225.
    1. Helmiö M, Victorzon M, Ovaska J, Leivonen M, Juuti A, Peromaa-Haavisto P, et al. Comparison of short-term outcome of laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: a prospective randomized controlled multicenter SLEEVEPASS study with 6-month follow up. Scand J Surg. 2014;103(3):175–181. doi: 10.1177/1457496913509984.
    1. Hong JS, Kim WW, Han SM. Five-year results of laparoscopic sleeve gastrectomy in Korean patients with lower body mass index. Obes Surg. 2014. [Epub ahead of print].
    1. Himpens J, Dobbeleir J, Peeters G. A long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010;2:319–24. doi: 10.1097/SLA.0b013e3181e90b31.
    1. Gadiot R, Biter LU, Zengerink HJ, de Vos tot Nederveen Cappel RJ, Elte JW, Castro Cabezas M, et al. Laparoscopic sleeve gastrectomy with an extensive posterior mobilization: technique and preliminary results. Obes Surg. 2012;2:320–9. doi: 10.1007/s11695-011-0488-9.
    1. The ENDOPATH® EMS Endoscopic Multifeed Stapler is a sterile single-patient-use instrument designed for use with the 10/11 mm diameter ENDOPATH Surgical Trocar. The device places rectangular titanium staples. Ethicon®.
    1. Fornari F, Madalosso CA, Farre R, Gurski RR, Thiesen V, Callegari-Jacques SM. The role of gastro-oesophageal pressure gradient and sliding hiatal hernia on pathological gastro-oesophageal reflux in severely obese patients. Eur J Gastroenterol Hepatol. 2010;22:404–11. doi: 10.1097/MEG.0b013e328332f7b8.
    1. van den Heuvel M, Horchner R, Wijtsma A, Bourhim N, Willemsen D, Mathus-Vliegen EM. Sweet eating: a definition and development of the Dutch Sweet Eating Questionnaire. Obes Surg. 2011;6:714–21. doi: 10.1007/s11695-010-0094-2.
    1. Lakdawala MA, Bhasker A, Mulchandani D, Goel S, Jain S. Comparison between the results of laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass in the Indian population: a retrospective 1 year study. Obes Surg. 2010;20:1–6. doi: 10.1007/s11695-009-9981-9.
    1. Peterli R, Wölnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, et al. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009;250:234–41. doi: 10.1097/SLA.0b013e3181ae32e3.
    1. Lee CM, Feng JJ, Cirangle PT, et al. Laparoscopic vertical sleeve gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2006;20(Suppl):255.
    1. Leyba JL, Llopis SN, Aulestia SN. Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the treatment of morbid obesity. A prospective study with 5 years of follow up. Obes Surg. 2014. [Epub ahead of print].
    1. Franco JV, Ruiz PA, Palermo M, Gagner M. A review of studies comparing three laparoscopic procedures in bariatric surgery: sleeve gastrectomy, Roux-en-Y gastric bypass and adjustable gastric banding. Obes Surg. 2011;9:1458–68. doi: 10.1007/s11695-011-0390-5.
    1. Tack J, Arts J, Caenepeel P, De Wulf D, Bisschops R. Pathophysiology, diagnosis and management of postoperative dumping syndrome. Nat Rev Gastroenterol Hepatol. 2009;6:583–90. doi: 10.1038/nrgastro.2009.148.
    1. Loss AB, de Souza AA, Pitombo CA, Milcent M, Madureira FA. Analysis of the dumping syndrome on morbid obese patients submitted to Roux en Y gastric bypass. Rev Col Bras Cir. 2009;36:413–9. doi: 10.1590/S0100-69912009000500009.
    1. Dalcanale L, Oliveira CP, Faintuch J, Nogueira MA, Rondó P, Lima VM, et al. Long-term nutritional outcome after gastric bypass. Obes Surg. 2010;20:181–7. doi: 10.1007/s11695-009-9916-5.
    1. Geubbels N, Bruin SC, Acherman YI, van de Laar AW, Hoen MB, de Brauw LM. Fast track care for gastric bypass patients decreases lenght of stay without increasing complications in an unselected patient cohort. Obes Surg. 2014;24:390–6. doi: 10.1007/s11695-013-1133-6.
    1. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187–96. doi: 10.1097/SLA.0b013e3181b13ca2.
    1. Chu CA, Gagner M, Guinn T, et al. Two stage laparoscopic biliopancreatic diversion with duodenal switch: an alternative approach to super-super morbid obesity. Surg Endosc. 2002;16:S069.
    1. Wölnerhanssen B, Peterli R. State of the art: sleeve gastrectomy. Dig Surg. 2014;1:40–7. doi: 10.1159/000354320.
    1. Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient. Surg Obes Relat Dis. 2010;6(1):112. doi: 10.1016/j.soard.2009.11.009.
    1. Garb J, Welch G, Zagarins S, Kuhn J, Romanelli J. Bariatric surgery for the treatment of morbid obesity: a meta-analysis of weight loss outcomes for laparoscopic adjustable band and laparoscopic gastric bypass. Obes Surg. 2009;19:1447–55.

Source: PubMed

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