Extended Pouch Roux-en-Y Gastric Bypass Study

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02218957
• Other study ID #: ExtPouch
• Status: Active, not recruiting
• Phase: N/A
• First received: August 13, 2014
• Last updated: June 2, 2016
• Start date: August 2014

Study information

• Verified date: June 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

• BMI 35 - 40 with a comorbidity

• or BMI > 40

Exclusion Criteria:

• Exclusion criteria for bariatric surgery (Fried Guidelines)

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Extended Pouch RYGB

• Standard RYGB

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	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.	2 years	Yes
Other	Quality of life	The quality of life will be assessed by using the BAROS.	2 years	No
Primary	Weight reduction	Excess weight loss (%EWL)	2 years	No
Secondary	Change in comorbidities	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: comorbidity resolved; comorbidity improved; comorbidity unchanged; comorbidity worsened; This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS.	2 years	No
Secondary	Change in comorbidities	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: comorbidity resolved; comorbidity improved; comorbidity unchanged; comorbidity worsened; This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.	2 years	No