Trials / Active Not Recruiting
Active Not RecruitingNCT05357807
Extending and Banding the Roux-en-Y Gastric Bypass
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 375 (actual)
- Sponsor
- Rijnstate Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
Detailed description
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain. A prospective randomize controlled trial. Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI \> 40 kg/m2 without any comorbidities. Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standard RYGB | Roux-en-Y Gastric bypass |
| PROCEDURE | Extended Pouch RYGB | Roux-en-Y gastric bypass with an extended pouch |
| PROCEDURE | Banded extended pouch RYGB | Roux-en-Y gastric bypass with a banded extended pouch |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2023-06-01
- Completion
- 2028-03-01
- First posted
- 2022-05-03
- Last updated
- 2024-06-21
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05357807. Inclusion in this directory is not an endorsement.