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Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity

Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00356213
Enrollment
217
Registered
2006-07-25
Start date
2006-10-30
Completion date
2017-08-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

morbid obesity, bariatric surgery, sleeve-gastrectomy, Roux-Y-gastric bypass, outcome, weight loss

Brief 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.

Interventions

PROCEDUREsleeve gastrectomy

laparoscopic sleeve gastrectomy

PROCEDURERoux-Y-gastric bypass

laparoscopic gastric bypass

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
Ethicon Endo-Surgery
CollaboratorINDUSTRY
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Swiss patients with approval by health insurance Patients from outside Switzerland: only if patients or their insurance will cover the costs Inclusion Criteria: * BMI\>40

Exclusion criteria

* contraindication for bariatric surgery

Design outcomes

Primary

MeasureTime frame
effectiveness in terms of weight loss, reduction in co-morbidity and quality of life5 years

Secondary

MeasureTime frame
early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026