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

NCT ID: NCT03838276

Last Updated: 2019-02-12

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

2019-02-15

Study Completion Date

2020-02-15

Brief Summary

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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

Detailed Description

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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

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AL150 BPL100

Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb

Group Type ACTIVE_COMPARATOR

AL 150 BPL100

Intervention Type PROCEDURE

Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb

AL100 BPL150

Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

Group Type EXPERIMENTAL

AL 100 BPL 150

Intervention Type PROCEDURE

Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

Interventions

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AL 150 BPL100

Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb

Intervention Type PROCEDURE

AL 100 BPL 150

Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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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Santiago de Battista

Role: STUDY_CHAIR

Hospital La PLata

Central Contacts

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Jaime Ruiz-Tovar

Role: CONTACT

630534808

Lucas Rivalletto

Role: CONTACT

+34654987159

Other Identifiers

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HRJC 19-21

Identifier Type: -

Identifier Source: org_study_id

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