Comparing two surgical methods for treating severe obesity
Randomized Clinical Trial Comparing Two Surgical Techniques for the Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S) and Roux-en-Y Gastric Bypass (RY-GBP)
NA · Hospital Clinic of Barcelona · NCT06789965
This study is testing two different weight loss surgeries for people with severe obesity to see which one helps them lose weight better and causes fewer problems afterward.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Locations | 1 site (Barcelona, Barcelona) |
| Trial ID | NCT06789965 on ClinicalTrials.gov |
What this trial studies
This study compares two surgical techniques for treating Type III obesity, specifically Single Anastomosis Duodenoileal Bypass with Sleeve Gastrectomy (SADI-S) and Roux-en-Y Gastric Bypass (RY-GBP). Both methods aim to reduce stomach size and limit calorie absorption, but their effectiveness in postoperative weight control and complications will be analyzed. The study is crucial as obesity is a growing epidemic, and understanding the best surgical approach could significantly impact patient outcomes. Participants will be monitored for weight loss and any gastroesophageal issues following the procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a BMI between 40 and 50 kg/m2 who are suitable for mixed bariatric surgery.
Not a fit: Patients outside the age range of 18 to 60 or with a BMI below 40 kg/m2 or above 50 kg/m2 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the more effective surgical technique for weight loss and improved health outcomes in patients with severe obesity.
How similar studies have performed: While both surgical techniques have been used in practice, there is limited comparative data on their effectiveness, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI 40 - 50 Kg/m2 * Candidates to mixed bariatric surgery Exclusion Criteria: * \< 18 years. * \> 60 years. * BMI \< 40 Kg/m2 * BMI \> 50 Kg/m2. * Non-candidates to mixed bariatric surgery.
Where this trial is running
Barcelona, Barcelona
- Hospital Clinic Barcelona — Barcelona, Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Javier Osorio, PhD — General & Digestive Surgery Department, ICMDM, Clinic Barcelona
- Study coordinator: Javier Osorio, PhD
- Email: josorio@clinic.cat
- Phone: +34932275400
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, obesity, sadi-s, ry-gbp, weight loss, metabolic complications, sadis, gbp