Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric
      bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients.
      In case of insufficient weight loss malabsorption can to be added by performing laparoscopic
      bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG)
      leads to changes in gastrointestinal hormones that are possibly different to bypassing the
      fundus (PGB).
    

Detailed description: 
      Background

      Obesity is reaching epidemic proportions in the developed world. In morbidly obese patients
      only surgical treatment (bariatric operations) leads to a sustained weight loss and cure of
      comorbidities in the majority of patients. There exist a number of different operations
      resulting in either a restrictive effect and/or malabsorption, accompanied by a humoral
      effect which is caused by changes of the different gastrointestinal hormones. It is still
      unknown which patients needs which operation.

      Working Hypothesis

      The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric
      bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients.
      In case of insufficient weight loss malabsorption can to be added by performing laparoscopic
      bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG)
      leads to changes in gastrointestinal hormones that are possibly different to bypassing the
      fundus (PGB).

      Specific Aims

      We plan to compare the SG and PGB in a prospective randomized study. Primary outcome measure
      is effectiveness in terms of weight loss, reduction in co-morbidity and quality of life,
      secondary outcome measures are early morbidity, duration and cost of the operation, late
      morbidity, re-operations (for complications, for insufficient weight loss), postoperative
      changes of gastrointestinal hormones.

      Experimental Design/Methods

      An interdisciplinary team evaluates morbidly obese patients for bariatric surgery. After
      informed consent eligible patients will be randomized into SG or PGB, a number of 45 per
      group. Preoperative examination consists of: quantification of comorbidity, eating behavior,
      indirect calorimetry, body composition by dual energy x-ray absorptiometry (DEXA), routine
      blood chemistry, gastrointestinal hormones before and after test meal, gastroscopy, manometry
      of the esophagus, upper GI series, abdominal ultrasound, quality of life. Perioperative
      investigations: operative time, fat tissue samples (omental and subcutaneous), early
      morbidity, gastrointestinal hormones before and after test meal, duration of hospital stay,
      costs; Follow-up data will be obtained every 3 months in the first year, twice in the second
      year and once per year thereafter: weight, reduction in comorbidities, blood tests,
      gastrointestinal hormones before and after test meal, DEXA and quality of life.
    

Intervention name(s): sleeve gastrectomy; Roux-Y-gastric bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic sleeve gastrectomy; laparoscopic gastric bypass
Other intervention name(s): bariatric operation; bariatric operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morbid obesity; bariatric surgery; sleeve-gastrectomy; Roux-Y-gastric bypass; outcome; weight loss