A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass
1 other identifier
interventional
192
1 country
1
Brief Summary
Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
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
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedNovember 5, 2020
November 1, 2020
1.9 years
June 15, 2020
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Weight loss
Measures: Weight in kilograms
12 months
Weight loss
Measures: Body Mass Index
12 months
Weight loss
Measures: Percent of excess weight loss
12 months
Weight loss
Measures: Percent of total weight loss
12 months
Secondary Outcomes (6)
Complete Diabetes Remission Rate
12 months
Major early complications
First 30 days
Major late complications
2-12 months
Nutritional status
12 months
Nutritional status
12 months
- +1 more secondary outcomes
Study Arms (2)
Long biliopancreatic limb
EXPERIMENTALPatients submitted to long biliopancreatic limb Roux-en-Y gastric bypass.
Standard biliopancreatic limb
ACTIVE COMPARATORPatients submitted to standard Roux-en-Y gastric bypass.
Interventions
Long biliopancreatic limb Roux-en-Y gastric bypass.
Standard Roux-en-Y gastric bypass
Eligibility Criteria
You may qualify if:
- Patient submitted to bariatric surgery
- All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity
You may not qualify if:
- Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Tlahuac
Mexico City, Mexico
Study Officials
- STUDY DIRECTOR
Carlos Zerrweck, MD
Head of Department. The Obesity Clinic at Hospital General Tlahuac
- PRINCIPAL INVESTIGATOR
Antonio Herrera, MD
The Obesity Clinic at Hospital General Tlahuac
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Head of Department.
Study Record Dates
First Submitted
June 15, 2020
First Posted
October 30, 2020
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share