NCT01686997

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 variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb 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 (short biliopancreatic limb) and long biliopancreatic limb RYGB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

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, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

3.5 years

First QC Date

September 13, 2012

Last Update Submit

June 2, 2016

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 (3)

  • Decrease in comorbidities

    2 years

  • Quality of life

    2 years

  • Complications and re-operations

    2 years

Study Arms (4)

Primairy long biliopancreatic limb RYGB

ACTIVE COMPARATOR

Roux limb 75 cm and Biliopancreatic Limb 150 cm

Procedure: Roux-en-Y Gastric Bypass

Redo Long biliopancreatic limb RYGB

ACTIVE COMPARATOR

Roux limb 75 cm and Biliopancreatic limb 150 cm

Procedure: Roux-en-Y Gastric Bypass

Primairy standard RYGB

ACTIVE COMPARATOR

Roux limb 150 cm and Biliopancreatic limb 75 cm

Procedure: Roux-en-Y Gastric Bypass

Redo standard RYGB

ACTIVE COMPARATOR

Roux limb 150 cm and Biliopancreatic limb 75 cm

Procedure: Roux-en-Y Gastric Bypass

Interventions

Roux-en-Y Gastric BypassPROCEDURE
Primairy long biliopancreatic limb RYGBPrimairy standard RYGBRedo Long biliopancreatic limb RYGBRedo 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
  • Redo- operation
  • medical history: gastric sleeve/ mason / gastric band
  • all BMI levels

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, Netherlands

Location

Related Publications (1)

  • Homan J, Boerboom A, Aarts E, Dogan K, van Laarhoven C, Janssen I, Berends F. A Longer Biliopancreatic Limb in Roux-en-Y Gastric Bypass Improves Weight Loss in the First Years After Surgery: Results of a Randomized Controlled Trial. Obes Surg. 2018 Dec;28(12):3744-3755. doi: 10.1007/s11695-018-3421-7.

    PMID: 30073496DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • F.J. Berends, MD, PhD

    Rijnstate Hospital

    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

September 13, 2012

First Posted

September 18, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

NL(1)