27
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      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

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references23

          • Record: found
          • Abstract: found
          • Article: not found

          Metabolic/bariatric surgery worldwide 2011.

          Metabolic/bariatric procedures for the treatment of morbid obesity, as well as for type 2 diabetes, are among the most commonly performed gastrointestinal operations today, justifying periodic assessment of the numerical status of metabolic/bariatric surgery and its relative distribution of procedures. An email questionnaire was sent to the leadership of the 50 nations or national groupings in the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Outcome measurements were numbers of metabolic/bariatric operations and surgeons, types of procedures performed, and trends from 2003 to 2008 to 2011 worldwide and in the regional groupings of Europe, USA/Canada, Latin/South America, and Asia/Pacific. Response rate was 84%. The global total number of procedures in 2011 was 340,768; the global total number of metabolic/bariatric surgeons was 6,705. The most commonly performed procedures were Roux-en-Y gastric bypass (RYGB) 46.6%; sleeve gastrectomy (SG) 27.8%; adjustable gastric banding (AGB) 17.8%; and biliopancreatic diversion/duodenal switch (BPD/DS) 2.2%. The global trends from 2003 to 2008 to 2011 showed a decrease in RYGB: 65.1 to 49.0 to 46.6%; an increase, followed by a steep decline, in AGB: 24.4 to 42.3 to 17.8%; and a marked increase in SG: 0.0 to 5.3 to 27.89%. BPD/DS declined: 6.1 to 4.9 to 2.1%. The trends from the four IFSO regions differed, except for the universal increase in SG. Periodic metabolic/bariatric surgery surveys add to the knowledge and understanding of all physicians caring for morbidly obese patients. The salient message of the 2011 assessment is that SG (0.0% in 2008) has markedly increased in prevalence.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            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.

            Bariatric surgery is currently the most effective treatment in morbidly obese patients, leading to durable weight loss. In this prospective double blind study, we aim to evaluate and compare the effects of laparoscopic Roux-en-Y gastric bypass (LRYGBP) with laparoscopic sleeve gastrectomy (LSG) on body weight, appetite, fasting, and postprandial ghrelin and peptide-YY (PYY) levels. After randomization, 16 patients were assigned to LRYGBP and 16 patients to LSG. Patients were reevaluated on the 1st, 3rd, 6th, and 12th postoperative month. Blood samples were collected after an overnight fast and in 6 patients in each group after a standard 420 kcal mixed meal. Body weight and body mass index (BMI) decreased markedly (P < 0.0001) and comparably after either procedure. Excess weight loss was greater after LSG at 6 months (55.5% +/- 7.6% vs. 50.2% +/- 6.5%, P = 0.04) and 12 months (69.7% +/- 14.6% vs. 60.5% +/- 10.7%, [P = 0.05]). After LRYGBP fasting ghrelin levels did not change significantly compared with baseline (P = 0.19) and did not decrease significantly after the test meal. On the other hand, LSG was followed by a marked reduction in fasting ghrelin levels (P < 0.0001) and a significant suppression after the meal. Fasting PYY levels increased after either surgical procedure (P < or = 0.001). Appetite decreased in both groups but to a greater extend after LSG. PYY levels increased similarly after either procedure. The markedly reduced ghrelin levels in addition to increased PYY levels after LSG, are associated with greater appetite suppression and excess weight loss compared with LRYGBP.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Long-term results of laparoscopic sleeve gastrectomy for obesity.

              To determine the mid- and long-term efficacy and possible side effects of laparoscopic sleeve gastrectomy as treatment for morbid obesity. Laparoscopic sleeve gastrectomy is still controversial as single and final treatment for morbid obesity. Some favorable short-term results have been published, however long-term results are still lacking. In the period between November 2001 and October 2002, 53 consecutive morbidly obese patients who, according to our personal algorithm, were qualified for restrictive surgery were selected for laparoscopic sleeve gastrectomy. Of the 53 patients, 11 received an additional malabsorptive procedure at a later stage because of weight regain. The percentage of excess weight loss (EWL) was assessed at 3 and 6 years postoperatively. A retrospective review of a prospectively collected database was performed for evaluation after 3 years. Recently, after the sixth postoperative year, patients were again contacted and invited to fill out a questionnaire. Full cooperation was obtained in 41 patients, a response rate of 78%. Although after 3 years a mean EWL of 72.8% was documented, after 6 years EWL had dropped to 57.3%, which according to the Reinhold criteria is still satisfactory. These results included 11 patients who had benefited from an additional malabsorptive procedure (duodenal switch) and 2 patients who underwent a "resleeve" between the third and sixth postoperative year. Analyzing the results of the subgroup of 30 patients receiving only sleeve gastrectomy, we found a 3-year %EWL of 77.5% and 6+ year %EWL of 53.3%. The differences between the third and sixth postoperative year were statistically significant in both groups. Concerning long-term quality of life patient acceptance stayed good after 6 + years despite the fact that late, new gastro-esophageal reflux complaints appeared in 21% of patients. In this long-term report of laparoscopic sleeve gastrectomy, it appears that after 6+ years the mean excess weight loss exceeds 50%. However, weight regain and de novo gastroesophageal reflux symptoms appear between the third and the sixth postoperative year. This unfavorable evolution might have been prevented in some patients by continued follow-up office visits beyond the third year. Patient acceptance remains good after 6+ years.
                Bookmark

                Author and article information

                Contributors
                u.biter@sfg.nl
                r.gadiot@sfg.nl
                b.grotenhuis@erasmusmc.nl
                m.dunkelgrun@sfg.nl
                s.vanmil@sfg.nl
                h.zengerink@sfg.nl
                frans.smulders@catharinaziekenhuis.nl
                g.mannaerts@sfg.nl
                Journal
                BMC Obes
                BMC Obes
                BMC obesity
                BioMed Central (London )
                2052-9538
                26 August 2015
                26 August 2015
                2015
                : 2
                : 30
                Affiliations
                [ ]Department of Surgery, St. Franciscus Gasthuis, Rotterdam, The Netherlands
                [ ]Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands
                Article
                58
                10.1186/s40608-015-0058-0
                4550059
                26316928
                63e7e0fb-bd98-456d-b05b-bb88c98be5d7
                © Biter et al. 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 22 July 2014
                : 16 June 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                bariatric surgery,sleeve,bypass
                bariatric surgery, sleeve, bypass

                Comments

                Comment on this article