RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm

February 9, 2019 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Ponderal Outcomes After Roux-en-Y Gastric Bypass With Alimentary Limb (AL) of 150cm and Biliopancreatic Limb (BPL) of 100cm vs AL 100cm and BPL 150cm

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

  • Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
  • Group 2: AL 100cm and BPL 150cm

Weight loss will be evaluated 1 year after surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

  • Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm
  • Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm

Weight loss will be evaluated 1 year after surgery

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 40 Kg/m2
  • BMI > 35 Kg/m2, associated with obesity-related comorbidities
  • Patients undergoing Roux-en-Y gastric bypass as bariatric procedure

Exclusion Criteria:

  • Patients undergoing Roux-en-Y gastric bypass as revisional procedure
  • Patients lost to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AL150 BPL100
Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
Procedure: AL 150 BPL100
Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
EXPERIMENTAL: AL100 BPL150
Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
Procedure: AL 100 BPL 150
Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 1 year after surgery
Weight loss will be assessed 1 year after surgery
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Study Chair: Santiago de Battista, Hospital La PLata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 15, 2019

Primary Completion (ANTICIPATED)

February 15, 2020

Study Completion (ANTICIPATED)

February 15, 2020

Study Registration Dates

First Submitted

February 9, 2019

First Submitted That Met QC Criteria

February 9, 2019

First Posted (ACTUAL)

February 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRJC 19-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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