Extended Pouch Roux-en-Y Gastric Bypass Study

Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02218957

Enrollment

130

Registered

2014-08-18

Start date

2014-07-31

Completion date

2018-07-31

Last updated

2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Bariatric surgery, Roux-en-Y Gastric Bypass

Brief summary

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.

Interventions

PROCEDUREExtended Pouch RYGB

PROCEDUREStandard RYGB

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Patient eligible for bariatric surgery according Fried guidelines Primary Gastric bypass * BMI 35 - 40 with a comorbidity * or BMI \> 40

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Weight reduction	2 years	Excess weight loss (%EWL)

Secondary

Measure	Time frame	Description
Change in comorbidities	2 years	Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups: 1. comorbidity resolved 2. comorbidity improved 3. comorbidity unchanged 4. comorbidity worsened This will be done for diabetes mellitus, hypertension, dyslipidemia and OSAS.

Other

Measure	Time frame	Description
Complications	2 years	Complications will be divided in short-term complications (within 30 days after operation) and long-term complications (after 30 days). All adverse event will be registered.
Quality of life	2 years	The quality of life will be assessed by using the BAROS.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026