NCT06794892Completed
Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional Procedures Following Failed Restrictive Bariatric Surgery
Comparative Outcomes of One-Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass As Revisional Procedures Following Failed Restrictive Bariatric Surgery: a Prospective Multicenter Study with Three-Year Follow-Up
Source: ClinicalTrials.gov · Last updated 28 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 328 (actual)
- First submitted
- 21 Jan 2025
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2021
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Diseases
- Obesity, High blood pressure, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06794892
What you commit to
- Study type: Observational
- Participants enrolled: 328
- From 1 Jan 2019 to the primary completion date, 31 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Revisional surgery performed for indications other than inadequate weight loss or weight regain (e.g., complications of the primary procedure such as stenosis or refractory gastroesophageal reflux, or for comorbidity management).
- History of prior gastric surgery unrelated to bariatric interventions.
Other illness
- Known psychiatric illness or untreated eating disorders.
Other
- Pregnancy.
Who the study is looking for
- Adults aged 18-65 years.
- Experienced insufficient weight loss, defined as:
- Excess weight loss (EWL) \< 50%.
- Total weight loss (TWL) \< 25%.
- BMI \> 40 kg/m² at least two years after primary restrictive surgery.
- Previously underwent laparoscopic sleeve gastrectomy (LSG) or laparoscopic adjustable gastric banding (LAGB).
- Undergoing revisional surgery specifically for inadequate weight loss or weight regain.
Criteria the registry did not label
- Eligibility Criteria
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lacco Ameno Via Fundera 2 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.