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NCT03838276 Clinical Trial

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

Weight Loss Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03838276
Other study ID # HRJC 19-21
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 15, 2019
Est. completion date February 15, 2020

Study information
Verified date February 2019
Source Hospital General Universitario Elche
Contact Jaime Ruiz-Tovar
Phone 630534808
Email jruiztovar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date February 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• AL 150 BPL100
Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
• AL 100 BPL 150
Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss Weight loss will be assessed 1 year after surgery 1 year after surgery
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