Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single anastomosis sleeve ileal bypass, Sleeve gastrectomy.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
Overview
This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.
Detailed description
Sleeve gastrectomy is an established therapeutic option for morbidly obese patients without preexisting gastroesophageal reflux disease. The novel single anastomosis sleeve ileal bypass (SASI) procedure is already introduced in Norway at a private high-volume bariatric hospital. The purpose of this study is to evaluate the effects of SASI in comparison to an established bariatric procedure, i.e. sleeve gastrectomy. The primary end point is 2-year changes in BMI after sleeve gastrectomy and SASI.
Interventions
- Procedure Single anastomosis sleeve ileal bypass
The abdominal cavity is entered directly (visual trocar) with or without the use of Verres needle. A 6-port set up and a liver retractor is utilized. A sleeve gastrectomy is performed as described below, but division of the stomach starts 6 cm proximal to the pylorus. The small bowel is measured 300cm from the ileocecal valve, with the small bowel stretched and markers placed on the graspers, and connected to the antrum of the stomach with a 45mm stapler. The anastomosis is positioned slightly v - Procedure Sleeve gastrectomy
In the laparoscopic sleeve gastrectomy, the abdominal cavity is entered directly with a visual trocar with or without the use of Verres needle. The set up includes a total of 5 ports. The Natanson liver retractor is utilized. The greater omentum is separated from the major side of the stomach from the pylorus to the angle of His. The left crus is visualized and the hiatus is inspected for the presence of hernia. A 36 French bougie is introduced and the stomach is divided along this from 4-5cm pr
Primary outcome measures
- Changes in body-mass index (BMI) [Time frame: 2 year]
Secondary outcome measures (12)
- Change in prevalence of esophagitis. [Time frame: 2 year]
- Change in prevalence of gastroesophageal reflux disease. [Time frame: 2 year]
- Complications [Time frame: 6 weeks (100 days for deaths), 2 year, 5 year]
- Obesity-related comorbid conditions. [Time frame: 2 year, 5 year]
- Vitamin concentrations [Time frame: 2 year, 5 year]
- Health-related quality of life [Time frame: 2 year, 5 year]
- Obesity-related symptoms [Time frame: 2 year, 5 year]
- Gastrointestinal symptoms [Time frame: 2 year, 5 year]
- Gastroesophageal reflux disease symptoms [Time frame: 2 year, 5 year]
- Bowel habits [Time frame: 2 year, 5 year]
- Revisional surgery [Time frame: 2 year, 5 year]
- Long-term changes in BMI [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Morbid obesity at referral for bariatric surgery (i.e. a body-mass index \[BMI\] of ≥35 kg/m2 with obesity-related comorbid conditions or ≥40 kg/m2 with or without such comorbidities).
- Age 20-60 years.
- Previous failed attempts of weight loss.
- Norwegian speaking patients.
Exclusion criteria
- BMI ≥55 kg/m2.
- A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio).
- Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery.
- Previous or current gastroesophageal reflux symptoms with daily use of antireflux medication. Patients are also excluded if preoperative manometry identifies a hiatal hernia (≥4cm in axial length) or if preoperative upper endoscopy identifies esophagitis grade C or D (LA classification), peptic stricture, Barrett's esophagus, or esophageal carcinoma.
- Achalasia
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Norway · 2 centers
- The Morbid Obesity Center, Vestfold Hospital Trust — Tønsberg
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT05611697 · 319260