BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass

May 2, 2020 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery

Patients will be randomized into 2 groups:

  • Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
  • Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm

Bone mineral density will be evaluated before surgery and 2 years after it.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized into 2 groups:

  • Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
  • Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)

Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index >40 Kg/m2
  • Body mass index >35 Kg/m2 associated to obesity related comorbidities

Exclusion Criteria:

  • Bone pathologies
  • Active neoplasms
  • Disorders in calcium or vitamin D metabolism

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biliopancreatic limb 60cm
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Procedure: biliopancreatic limb length of 60cm.
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
ACTIVE_COMPARATOR: Biliopancreatic limb 100cm
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
Procedure: biliopancreatic limb length of 100cm.
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: 2 years after surgery
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
2 years after surgery

Collaborators and Investigators

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

Sponsor

Hospital General Universitario Elche

Collaborators

Instituto de Seguridad Social del Estado de Mexico y Municipios

Investigators

  • Principal Investigator: Jaime Ruiz-Tovar, Garcilaso Clinic

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)

May 7, 2020

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 2, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Garcilaso-Mex 20-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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