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

Primary Purpose

Weight Loss

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL 150 BPL100
AL 100 BPL 150
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    AL150 BPL100

    AL100 BPL150

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Weight loss
    Weight loss will be assessed 1 year after surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2019
    Last Updated
    February 9, 2019
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03838276
    Brief Title
    RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2019 (Anticipated)
    Primary Completion Date
    February 15, 2020 (Anticipated)
    Study Completion Date
    February 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AL150 BPL100
    Arm Type
    Active Comparator
    Arm Description
    Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
    Arm Title
    AL100 BPL150
    Arm Type
    Experimental
    Arm Description
    Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
    Intervention Type
    Procedure
    Intervention Name(s)
    AL 150 BPL100
    Intervention Description
    Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
    Intervention Type
    Procedure
    Intervention Name(s)
    AL 100 BPL 150
    Intervention Description
    Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight loss will be assessed 1 year after surgery
    Time Frame
    1 year after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jaime Ruiz-Tovar
    Phone
    630534808
    Email
    jruiztovar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lucas Rivalletto
    Phone
    +34654987159
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Santiago de Battista
    Organizational Affiliation
    Hospital La PLata
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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