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Creating a Laparoscopic Banded Sleeve Gastrectomy

NCT04610099 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2024-06-28

No results posted yet for this study

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.

Conditions

  • Morbid Obesity

Interventions

DEVICE

Banded Sleeve Gastrectomy

banded sleeve gastrectomy

DEVICE

Standard SG

Standard SG

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Hazebroek · Rijnstate Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2025-12-31
Completion
2026-03-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610099 on ClinicalTrials.gov