Trials / Active Not Recruiting
Active Not RecruitingNCT04610099
Creating a Laparoscopic Banded Sleeve Gastrectomy
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- Rijnstate Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.
Detailed description
A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy. Study is a prospective, randomized, multi centre trial. Study population: patients who qualify for a SG are eligible to participate. The primary SG patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher. Intervention: The standard SG is compared with a banded-SG (BSG)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Banded Sleeve Gastrectomy | banded sleeve gastrectomy |
| DEVICE | Standard SG | Standard SG |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2025-12-31
- Completion
- 2026-03-01
- First posted
- 2020-10-30
- Last updated
- 2024-06-28
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04610099. Inclusion in this directory is not an endorsement.