Comparison of laparoscopic and robotic-assisted gastric bypass surgeries
A Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastric Bypass and Sleeve Gastrectomy
Methodist Health System · NCT05224791
This study is trying to see if laparoscopic or robotic-assisted gastric bypass surgeries work better and are safer for people with severe obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Methodist Health System (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05224791 on ClinicalTrials.gov |
What this trial studies
This observational study compares the outcomes of laparoscopic and robotic-assisted Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy procedures. It includes patients who underwent these surgeries between 2017 and 30 days prior to the institution's IRB approval date. The study aims to evaluate the effectiveness and safety of these surgical approaches in treating severe obesity and related comorbidities. Data will be collected from multiple centers to provide a comprehensive analysis of patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI over 35 and obesity-related comorbidities or a BMI over 40.
Not a fit: Patients who underwent emergency or revisional bariatric procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective surgical approach for weight loss and improvement of obesity-related health conditions.
How similar studies have performed: Previous studies have shown positive outcomes with laparoscopic bariatric surgeries, but this specific comparison of robotic-assisted techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject was 18 years or older at the time of procedure * Subject who has undergone either laparoscopic or robotic-assisted RYGB or SG between the time frame of 30 days prior to institution's IRB approval date and the year 2017 * Subject has one of the below qualifications: 1. Body mass index (BMI) \> 40 kg/m2 or more than 100 pounds overweight OR 2. BMI \> 35 kg/m2 and one of the following obesity-related co-morbidities such as type II diabetes mellitus, hypertension, sleep apnea and other respiratory disorders, non- alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease. Exclusion Criteria: * Subject who underwent RYGB or SG as an emergent procedure * Subject who underwent RYGB or SG as revisional bariatric procedure * Subject who underwent RYGB or SG as a secondary (concomitant) procedure and not as a primary procedure
Where this trial is running
Dallas, Texas
- Minimally Invasive Surgical Associates, Methodist Dallas Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Sachin S Kukreja, MD — The Methodist Hospital Research Institute
- Study coordinator: Colette Ngo Ndjom
- Email: ClinicalResearch@mhd.com
- Phone: 214-947-4681
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: Laparoscopic Sleeve Gastrectomy, Sleeve Gastrectomy, laparoscopic, robotic-assisted RYGB