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

Primary Purpose

Osteopenia

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
biliopancreatic limb length of 60cm.
biliopancreatic limb length of 100cm.
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Biliopancreatic limb 60cm

    Biliopancreatic limb 100cm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Bone mineral density
    Bone mineral density will be evealuated by absorptiometry at the level of lumbar column

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2020
    Last Updated
    May 2, 2020
    Sponsor
    Hospital General Universitario Elche
    Collaborators
    Instituto de Seguridad Social del Estado de Mexico y Municipios
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04377230
    Brief Title
    BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass
    Official Title
    Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 7, 2020 (Anticipated)
    Primary Completion Date
    May 1, 2022 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche
    Collaborators
    Instituto de Seguridad Social del Estado de Mexico y Municipios

    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
    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
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The radiologist evaluating bone mineral density will be blinded to the biliopancreatic limb length
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Biliopancreatic limb 60cm
    Arm Type
    Experimental
    Arm Description
    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
    Arm Title
    Biliopancreatic limb 100cm
    Arm Type
    Active Comparator
    Arm Description
    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
    Intervention Type
    Procedure
    Intervention Name(s)
    biliopancreatic limb length of 60cm.
    Intervention Description
    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
    Intervention Type
    Procedure
    Intervention Name(s)
    biliopancreatic limb length of 100cm.
    Intervention Description
    Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
    Primary Outcome Measure Information:
    Title
    Bone mineral density
    Description
    Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
    Time Frame
    2 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolina LLavero Garrido
    Phone
    649593020
    Email
    carolinallavero@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gilberto Gonzalez
    Phone
    +5213322545864
    Email
    gilpchmd@yahoo.com.mx
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaime Ruiz-Tovar
    Organizational Affiliation
    Garcilaso Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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