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

NCT ID: NCT04377230

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-07

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The radiologist evaluating bone mineral density will be blinded to the biliopancreatic limb length

Study Groups

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Biliopancreatic limb 60cm

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.

Group Type EXPERIMENTAL

biliopancreatic limb length of 60cm.

Intervention Type PROCEDURE

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.

Biliopancreatic limb 100cm

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

Group Type ACTIVE_COMPARATOR

biliopancreatic limb length of 100cm.

Intervention Type PROCEDURE

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

Interventions

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biliopancreatic limb length of 60cm.

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.

Intervention Type PROCEDURE

biliopancreatic limb length of 100cm.

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Seguridad Social del Estado de Mexico y Municipios

OTHER_GOV

Sponsor Role collaborator

Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar

Role: PRINCIPAL_INVESTIGATOR

Garcilaso Clinic

Central Contacts

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Carolina LLavero Garrido

Role: CONTACT

649593020

Gilberto Gonzalez

Role: CONTACT

+5213322545864

Other Identifiers

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Garcilaso-Mex 20-3

Identifier Type: -

Identifier Source: org_study_id

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