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Netherlands’ bariatric trial

Sleeve Bypass Trial to compare procedures out to 5 years

The study will contribute to the evidence of the benefits of LSG versus the standard LRYGB

A Netherlands’ based randomised, two-centre clinical trial will assess laparoscopic roux-en-y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) to evaluate the efficiency of both techniques, with the hypothesis that LSG has a similar percentage excess BMI loss (%EBMIL) after five years compared to LRYGB. The outline of the trial in described in a paper, ‘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.’, by investigators from St Franciscus Gasthuis, Rotterdam and Catharina Ziekenhuis, Eindhoven, The Netherlands is featured online in BMC Obesity.

Patients eligible for the Sleeve Bypass Trial have a BMI≥40 or BMI>35 with obesity related comorbidity (T2DM, sleep apnoea, hypertension) are eligible for randomisation. Preoperatively all patients are assessed by an multidisciplinary team consisting of at least surgeons, endocrinologists, physiotherapists, nutritionists, and psychiatrists.

The study is recruiting 620 patients who will be equally (1:1) randomised to either procedure. Secondary endpoints are resolution of obesity related comorbidity, complications, revision bariatric surgery and quality of life (QOL) defined in various questionnaires. The study started on November 24th 2012 and the duration of the inclusion will be approximately three years. The complete route of patient inclusion and randomisation is depicted in Figure 1.

Figure 1: CONSORT flowchart

Patients will be randomised (using a randomization website) to one of the following bariatric procedures:

  • The LSG is performed by a full mobilisation of the greater curvature and the posterior stomach, followed by stapling calibrated over a 34 french boogie, starting 2–3cms from the pylorus.
  • The LRYGB is performed with the antecolic linear technique. A small 4cm long pouch is calibrated over a 34 french boogie and 3cm linear gastroenterostomy is realized. The measured biliopancreatic limb is 60cm and the alimentary limb is 150cm. The omentum can be divided at the surgeons’ discretion. Both mesenteric defects are closed with clips.

“Currently, only few randomized controlled trials have compared LSG and LRYGB,” the authors conclude. “However, these studies described small study groups and did not report long-term results. Although their conclusions lack hard evidence to determine in which patients these two different techniques should be performed, these studies seem to show a small short term beneficial result for LSG. This study will contribute to the evidence of the benefits of LSG versus the standard LRYGB.”

To access this paper, please click here

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