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NOT YET RECRUITING
NCT06204939
NA

Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45

Sponsor: L. van Hogezand

View on ClinicalTrials.gov

Summary

The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.

Official title: Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-06-01

Completion Date

2029-12-01

Last Updated

2024-01-12

Healthy Volunteers

Yes

Interventions

PROCEDURE

Randomizing for EPGB procedure

Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.

PROCEDURE

Randomizing for OAGB procedure

Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.