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RECRUITING
NCT04894838
NA

DIStal gastriC Bypass OUtcome in Revision SurgEry After Roux-en-y Gastric Bypass

Sponsor: St. Antonius Hospital

View on ClinicalTrials.gov

Summary

This study is designed as a prospective multicenter randomized controlled clinical trial comparing two surgical techniques of distal gastric bypass (DGB) in revisional surgery following failed Roux-en-Y gastric bypass. Patients will be randomly allocated 1:1 to A) DGB with lengthening of the BPL (DGB type I) or B) DGB with extended AL (DGB type II). Randomisation is stratified for participating center. The study will be performed in a clinical and out-patient setting with regular visits at 1.5, 3, 6, 12, 18, 24 and 36 months post intervention. The study will be set up as a multicenter study with bariatric centers: St. Antonius hospital, Groene Hart hospital, OLVG, Rijnstate hospital, Elisabeth Twee-steden Hospital, Bravis hospital, Medisch Centrum Leeuwarden, Catharina Hospital.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-05-01

Completion Date

2027-05

Last Updated

2024-07-08

Healthy Volunteers

No

Interventions

PROCEDURE

Distal gastric bypass

Distal gastric bypass, revisonal surgery after failed RYGB

Locations (8)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Bravis Hospital

Roosendaal, North Brabant, Netherlands

Elisabeth-Tweesteden Hospital

Tilburg, North Brabant, Netherlands

OLVG

Amsterdam, North Holland, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Groene Hart Hospital

Gouda, South Holland, Netherlands

St. Antonius hospital

Nieuwegein, Utrecht, Netherlands