Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional Procedures Following Failed Restrictive Bariatric Surgery
NCT06794892 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 328
Last updated 2025-01-28
Summary
Study Description
This prospective, multicenter study aims to compare the outcomes of One-Anastomosis Gastric Bypass (OAGB) and Roux-en-Y Gastric Bypass (RYGB) as revisional procedures for patients experiencing insufficient weight loss or weight regain following restrictive bariatric surgeries, such as laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB). Conducted between January 2019 and December 2021, the study involves a three-year follow-up of 328 patients across high-volume bariatric centers.
The primary objective is to evaluate the effectiveness of these revisional procedures in achieving additional weight loss. Secondary objectives include analyzing differences in operative times, complication rates (short- and long-term), reduction of obesity-related comorbidities, mortality, and overall patient outcomes.
This study uniquely integrates comprehensive pre- and postoperative assessments, including radiological evaluations, to better understand predictors of success and provide evidence for optimal surgical strategies in revisional bariatric care.
Conditions
- Obesity, Morbid
- Type 2 Diabetes Mellitus (T2DM)
- Hypertension
- Dyslipidemia
Sponsors & Collaborators
-
University of Campania Luigi Vanvitelli
collaborator OTHER -
Azienda Sanitaria Locale Napoli 2 Nord
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-01
- Primary Completion
- 2021-12-31
- Completion
- 2024-01-30
Countries
- Italy
Study Locations
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