Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass

Ralph Peterli, Yves Borbély, Beatrice Kern, Markus Gass, Thomas Peters, Martin Thurnheer, Bernd Schultes, Kurt Laederach, Marco Bueter, Marc Schiesser, Ralph Peterli, Yves Borbély, Beatrice Kern, Markus Gass, Thomas Peters, Martin Thurnheer, Bernd Schultes, Kurt Laederach, Marco Bueter, Marc Schiesser

Abstract

Objective: Laparoscopic sleeve gastrectomy (LSG) has been proposed as an effective alternative to the current standard procedure, laparoscopic Roux-en-Y gastric bypass (LRYGB). Prospective data comparing both procedures are rare. Therefore, we performed a randomized clinical trial assessing the effectiveness and safety of these 2 operative techniques.

Methods: Two hundred seventeen patients were randomized at 4 bariatric centers in Switzerland. One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line, and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb. The mean body mass index of all patients was 44 ± 11.1 kg/m, the mean age was 43 ± 5.3 years, and 72% were female.

Results: The 2 groups were similar in terms of body mass index, age, sex, comorbidities, and eating behavior. The mean operative time was less for LSG than for LRYGB (87 ± 52.3 minutes vs 108 ± 42.3 minutes; P = 0.003). The conversion rate was 0.9% in both groups. Complications (<30 days) occurred more often in LRYGB than in LSG (17.2% vs 8.4%; P = 0.067). However, the difference in severe complications did not reach statistical significance (4.5% for LRYGB vs 1% for LSG; P = 0.21). Excessive body mass index loss 1 year after the operation was similar between the 2 groups (72.3% ± 22% for LSG and 76.6% ± 21% for LRYGB; P = 0.2). Except for gastroesophageal reflux disease, which showed a higher resolution rate after LRYGB, the comorbidities and quality of life were significantly improved after both procedures.

Conclusions: LSG was associated with shorter operation time and a trend toward fewer complications than with LRYGB. Both procedures were almost equally efficient regarding weight loss, improvement of comorbidities, and quality of life 1 year after surgery. Long-term follow-up data are needed to confirm these facts.

Figures

FIGURE 1.
FIGURE 1.
A, Change in BMI (means ± standard error). B, EBMIL (means).
FIGURE 2.
FIGURE 2.
Reduction in comorbidity 1 year after surgery. No significant difference in cure or improvement of comorbidities between LSG and LRYGB except for GERD (*P = 0.008). GERD indicates gastro esophageal reflux disease; OSAS, obstructive sleep apnea syndrome; T2DM, type 2 diabetes.

References

    1. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724–1737
    1. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366:1567–1576
    1. Sjostrom L, Lindroos AK, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004;351:2683–2693
    1. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366:1577–1585
    1. Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009;361:445–454
    1. Adams TD, Davidson LE, Litwin SE, et al. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012;308:1122–1131
    1. Regan JP, Inabnet WB, Gagner M, et al. Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Obes Surg. 2003;13:861–864
    1. Deitel M, Gagner M, Erickson AL, et al. Third International Summit: current status of sleeve gastrectomy. Surg Obes Relat Dis. 2011;7:749–759
    1. Bellanger DE, Greenway FL. Laparoscopic sleeve gastrectomy, 529 cases without a leak: short-term results and technical considerations. Obes Surg. 2011;21:146–150
    1. Himpens J, Dobbeleir J, Peeters G. Long-term results of laparoscopic sleeve gastrectomy for obesity. Ann Surg. 2010;252:319–324
    1. Sarela AI, Dexter SP, O'Kane M, et al. Long-term follow-up after laparoscopic sleeve gastrectomy: 8–9-year results. Surg Obes Relat Dis. 2012;8:679–684
    1. Spyropoulos C, Argentou MI, Petsas T, et al. Management of gastrointestinal leaks after surgery for clinically severe obesity. Surg Obes Relat Dis. 2012;8:609–615
    1. 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 >12,000 cases. Surg Obes Relat Dis. 2012;8:8–19
    1. Karamanakos SN, Vagenas K, Kalfarentzos F, et al. 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;247:401–407
    1. Kehagias I, Karamanakos SN, Argentou M, et al. 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;21:1650–1656
    1. Woelnerhanssen B, Peterli R, Steinert RE, et al. Effects of postbariatric surgery weight loss on adipokines and metabolic parameters: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy—a prospective randomized trial. Surg Obes Relat Dis. 2011;7:561–568
    1. Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009;19:1605–1611
    1. Eypasch E, Williams JI, Wood-Dauphinee S, et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995;82:216–222
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–213
    1. Helmio M, Victorzon M, Ovaska J, et al. SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. Surg Endosc. 2012;26:2521–2526
    1. Jurowich C, Thalheimer A, Seyfried F, et al. Gastric leakage after sleeve gastrectomy-clinical presentation and therapeutic options. Langenbecks Arch Surg. 2011;396:981–987
    1. Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012;8:e21–e26
    1. Gagniere J, Slim K, Launay-Savary MV, et al. Previous gastric banding increases morbidity and gastric leaks after laparoscopic sleeve gastrectomy for obesity. J Visc Surg. 2011;148:e205–e209
    1. Peterli R, Steinert RE, Woelnerhanssen B, et al. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg. 2012;22:740–748
    1. Peterli R, Wolnerhanssen B, Peters T, 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;250:234–241
    1. Bueter M, Lowenstein C, Olbers T, et al. Gastric bypass increases energy expenditure in rats. Gastroenterology. 2010;138:1845–1853
    1. Bueter M, le Roux CW. Gastrointestinal hormones, energy balance and bariatric surgery. Int J Obes (Lond). 2011;35(suppl 3):S35–S39
    1. Finkelstein EA, Trogdon JG, Cohen JW, et al. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009;28:w822–w831

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere