Creating a Laparoscopic Banded Sleeve Gastrectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Morbid Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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...
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)
Tracking Information
- NCT #
- NCT04610099
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hazebroek Rijnstate Hospital