Extended Pouch Roux-en-Y Gastric Bypass Study

NCT ID: NCT02218957

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-07-31

Brief Summary

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Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard RYGB

Standard RYGB

Group Type ACTIVE_COMPARATOR

Standard RYGB

Intervention Type PROCEDURE

Extended Pouch RYGB

Restrictive/extended pouch RYGB

Group Type EXPERIMENTAL

Extended Pouch RYGB

Intervention Type PROCEDURE

Interventions

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Extended Pouch RYGB

Intervention Type PROCEDURE

Standard RYGB

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

* BMI 35 - 40 with a comorbidity
* or BMI \> 40

Exclusion Criteria

* Patients with language problems that interveins to follow medical advises
* Genetic diseases that intervens to follow medical advises
* Chronic bowel diseases
* Nephrologic (MDRD \<30) of liver diseases (AST/ALT more than twice the norm)
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Homan, MD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital Arnhem

Locations

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Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ExtPouch

Identifier Type: -

Identifier Source: org_study_id

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