Comparing two surgical options for treating morbid obesity
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial
NA · Oslo University Hospital · NCT05611697
This study is testing whether a new type of weight loss surgery called SASI works better than the traditional sleeve gastrectomy for people with severe obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 2 sites (Tønsberg, Vestfold and 1 other locations) |
| Trial ID | NCT05611697 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of two bariatric surgical procedures: the single anastomosis sleeve ileal bypass (SASI) and sleeve gastrectomy. It aims to evaluate weight loss outcomes, gastroesophageal reflux, and the impact on obesity-related comorbidities in morbidly obese patients. The primary endpoint is the change in body mass index (BMI) over two years following the procedures. The SASI procedure is a newer approach that has been introduced in Norway, and this study seeks to determine its efficacy compared to the established sleeve gastrectomy.
Who should consider this trial
Good fit: Ideal candidates for this study are Norwegian-speaking adults aged 20-60 with morbid obesity and a BMI of 35 kg/m2 or higher, who have previously attempted weight loss.
Not a fit: Patients with a BMI of 55 kg/m2 or higher, a history of major abdominal surgery, or established gastroesophageal reflux disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective surgical options for morbidly obese patients, potentially leading to better weight loss outcomes and improved health.
How similar studies have performed: While the SASI procedure is relatively novel, previous studies on similar bariatric procedures have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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). 2. Age 20-60 years. 3. Previous failed attempts of weight loss. 4. Norwegian speaking patients. Exclusion Criteria: 1. BMI ≥55 kg/m2. 2. A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio). 3. Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery. 4. 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. 5. Achalasia 6. Pregnancy.
Where this trial is running
Tønsberg, Vestfold and 1 other locations
- The Morbid Obesity Center, Vestfold Hospital Trust — Tønsberg, Vestfold, Norway (NOT_YET_RECRUITING)
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Torgeir T Søvik, MD, PhD — Oslo University Hospital
- Study coordinator: Helene M Haug, MD
- Email: b31831@ous-hf.no
- Phone: +47 22 11 80 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Morbid, procedure: sleeve gastrectomy, bariatric surgery, procedure: single anastomosis sleeve ileal bypass