Extending and Banding the Roux-en-Y Gastric Bypass

NCT ID: NCT05357807

Last Updated: 2024-06-21

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2028-03-01

Brief Summary

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The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

Detailed Description

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The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

A prospective randomize controlled trial.

Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI \> 40 kg/m2 without any comorbidities.

Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.

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

127 patients undergo a standard Roux-en-Y gastric bypass

Group Type ACTIVE_COMPARATOR

Standard RYGB

Intervention Type PROCEDURE

Roux-en-Y Gastric bypass

Extended Pouch RYGB

127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.

Group Type EXPERIMENTAL

Extended Pouch RYGB

Intervention Type PROCEDURE

Roux-en-Y gastric bypass with an extended pouch

Banded Extended RYGB

127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.

Group Type EXPERIMENTAL

Banded extended pouch RYGB

Intervention Type PROCEDURE

Roux-en-Y gastric bypass with a banded extended pouch

Interventions

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Standard RYGB

Roux-en-Y Gastric bypass

Intervention Type PROCEDURE

Extended Pouch RYGB

Roux-en-Y gastric bypass with an extended pouch

Intervention Type PROCEDURE

Banded extended pouch RYGB

Roux-en-Y gastric bypass with a banded extended pouch

Intervention Type PROCEDURE

Other Intervention Names

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S-RYGB EP-RYGB BEP-RYGB

Eligibility Criteria

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Inclusion Criteria

* All patients who are eligible for a primary RYGB

Exclusion Criteria

* Bariatric surgery in medical history
* Patients with a language barrier which may affect the compliance with medical advice
* Patients with a disease not related to morbid obesity, such as Cushing or drug related.
* Chronic bowel disease for example Crohn's disease or colitis Colitis.
* Renal impairment (MDRD \<30)
* Hepatic dysfunction (liver function twice the normal values)
* Pregnancy during follow-up
* Patients with treatment-resistant reflux symptoms.
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

Locations

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Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Site Status

NOK West

The Hague, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL62168.091.17

Identifier Type: -

Identifier Source: org_study_id

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