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Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass

Primary Purpose

Weight Loss

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BP limb 70cm
BP limb 120cm
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
  • Age older than 18 years

Exclusion Criteria:

  • Patients undergoing other bariatric techniques than RYGB
  • Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
  • Any other surgical procedure added to the bariatric surgery
  • Impossibility to comply with pre-established clinical follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    BP limb 70cm

    BP limb 120cm

    Arm Description

    Patients underwent a RYGB with a biliopancreatic limb of 70cm

    Patients underwent a RYGB with a biliopancreatic limb of 120cm

    Outcomes

    Primary Outcome Measures

    Weight loss
    Weight loss was evaluated

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2018
    Last Updated
    July 23, 2018
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03607305
    Brief Title
    Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass
    Official Title
    Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (Actual)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    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
    Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm. Excess BMI loss 5 years after surgery was investigated
    Detailed Description
    Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm). Excess BMI loss 5 years after surgery was investigated

    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
    506 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BP limb 70cm
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent a RYGB with a biliopancreatic limb of 70cm
    Arm Title
    BP limb 120cm
    Arm Type
    Experimental
    Arm Description
    Patients underwent a RYGB with a biliopancreatic limb of 120cm
    Intervention Type
    Procedure
    Intervention Name(s)
    BP limb 70cm
    Intervention Description
    Performance of RYGB with a BP limb of 70cm
    Intervention Type
    Procedure
    Intervention Name(s)
    BP limb 120cm
    Intervention Description
    Performance of RYGB with a BP limb of 120cm
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight loss was evaluated
    Time Frame
    5 years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity Age older than 18 years Exclusion Criteria: Patients undergoing other bariatric techniques than RYGB Patients undergoing RYGB with different BPL or AL lengths than that reported for this study Any other surgical procedure added to the bariatric surgery Impossibility to comply with pre-established clinical follow-up.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaime Ruiz-Tovar
    Organizational Affiliation
    HOSPITAL REY JUAN CARLOS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31104282
    Citation
    Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7.
    Results Reference
    derived

    Learn more about this trial

    Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass

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