NCT01252511

Brief Summary

The purpose of this study is to determine whether or not the length of the biliopancreatic limb of the Roux-en-Y anastamosis plays a critical role in the development of malabsorption after gastric bypass for treatment of severe obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

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

First Submitted

Initial submission to the registry

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2017

Completed
Last Updated

May 17, 2019

Status Verified

January 1, 2016

Enrollment Period

3.6 years

First QC Date

December 1, 2010

Last Update Submit

May 15, 2019

Conditions

Severe Obesity

Keywords

Malabsorption after RYGBFat Malabsorption and maldigestionObesity surgeryBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Selective fat malabsorption

    To learn how to create an operation resulting in the predominance of fat malabsorption over protein malabsorption.

    1 year after RYGB surgery

Study Arms (2)

long biliopancreatic limb, 75 cm

ACTIVE COMPARATOR
Procedure: RYGB for surgical treatment of severe obesity

long Roux limb, 150 cm

ACTIVE COMPARATOR
Procedure: RYGB for surgical treatment of severe obesity

Interventions

RYGB for surgical treatment of severe obesityPROCEDURE

Twenty severely obese patients who have been scheduled to receive long limb RYGB will be enrolled in the study. By randomization, 10 patients will have a biliopancreatic limb that includes 40 cm of jejunum and a Roux limb that contains 150 cm of jejunum. The other 10 patients will receive a biliopancreatic limb that contains 75 cm of jejunum and a Roux limb of 115 cm.

long Roux limb, 150 cmlong biliopancreatic limb, 75 cm

Eligibility Criteria

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

You may qualify if:

  • Patients with severe obesity (BMI equal to or greater than 50) who have been scheduled to receive Roux-en-Y gastric bypass.

You may not qualify if:

  • Previous abdominal surgery, chronic diarrhea, and severe constipation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • John S Fordtran, MD

    Baylor Health Care System

    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

December 1, 2010

First Posted

December 3, 2010

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

January 14, 2017

Last Updated

May 17, 2019

Record last verified: 2016-01

Locations

US(1)