NCT02218957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

August 13, 2014

Last Update Submit

June 17, 2024

Conditions

Morbid Obesity

Keywords

Bariatric surgeryRoux-en-Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

  • Weight reduction

    Excess weight loss (%EWL)

    2 years

Secondary Outcomes (2)

  • Change in comorbidities

    2 years

  • Change in comorbidities

    2 years

Other Outcomes (2)

  • Complications

    2 years

  • Quality of life

    2 years

Study Arms (2)

Standard RYGB

ACTIVE COMPARATOR

Standard RYGB

Procedure: Standard RYGB

Extended Pouch RYGB

EXPERIMENTAL

Restrictive/extended pouch RYGB

Procedure: Extended Pouch RYGB

Interventions

Extended Pouch RYGBPROCEDURE
Extended Pouch RYGB
Standard RYGBPROCEDURE
Standard RYGB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800WC, Netherlands

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Homan, MD

    Rijnstate Hospital Arnhem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 18, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2018

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

NL(1)