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Duodenal Switch With a Standard Versus Long Alimentary Limb (Long_limb_DS)

Primary Purpose

Obesity, Morbid, Bariatric Surgery Candidate, Metabolism Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Long alimentary limb BPD-DS
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities

Exclusion Criteria:

  • BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard BPD-DS

    Long alimentary limb BPD-DS

    Arm Description

    Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel

    BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel

    Outcomes

    Primary Outcome Measures

    Total weight change
    Changes in total body weight, in kg, from baseline

    Secondary Outcome Measures

    Changes in Gastro-intestinal side-effects scores
    Gastro-intestinal symptoms assessed by measuring changes in GI Score
    Changes in Quality of life
    Measure of Quality of life using Short-Form 36

    Full Information

    First Posted
    January 2, 2017
    Last Updated
    March 23, 2018
    Sponsor
    Laval University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03097926
    Brief Title
    Duodenal Switch With a Standard Versus Long Alimentary Limb
    Acronym
    Long_limb_DS
    Official Title
    Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    March 2018 (Actual)
    Study Completion Date
    March 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Laval University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein deficiency, vitamin and trace element deficit compared to standard BPD-DS.
    Detailed Description
    This two-group, randomized, single-blind pilot study is conducted in a university-affiliated tertiary care center. The study protocol was approved by our ethic committee. Enrollment and randomization of the patients occurred between May 20163 and June 2015. Patients are undergoing follow-up evaluation. Patients were initially referred to our center for a bariatric surgery evaluation. Eligible patients were 18 years of age or older and met the criteria for a laparoscopic biliopancreatic diversion. Patients were excluded if they had a BMI ≥ 50 mg/m², a pacemaker, cirrhosis or if they were planing pregnancy in the next 2 years. Each patient was required to provide written informed consent. Patients were randomly assigned in a 1:1 ratio to undergo a standard biliopancreatic diversion (control group) or a modified biliopancreatic diversion with a longer strict alimentary limb (study group). A sealed envelope with the assignation was given to the surgeon in the operation room just before the procedure. Patients are followed every 6 months after surgery, up to 24-months for clinical evaluation, resolution of comorbidities, evaluation of side-effects, quality of life, bioimpedance testing and bloodwork.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid, Bariatric Surgery Candidate, Metabolism Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard BPD-DS
    Arm Type
    Active Comparator
    Arm Description
    Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel
    Arm Title
    Long alimentary limb BPD-DS
    Arm Type
    Experimental
    Arm Description
    BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel
    Intervention Type
    Procedure
    Intervention Name(s)
    Long alimentary limb BPD-DS
    Intervention Description
    BPD-DS with a long strict alimentary limb and a 100-cm common channel.
    Primary Outcome Measure Information:
    Title
    Total weight change
    Description
    Changes in total body weight, in kg, from baseline
    Time Frame
    6, 12, 18, 24 months
    Secondary Outcome Measure Information:
    Title
    Changes in Gastro-intestinal side-effects scores
    Description
    Gastro-intestinal symptoms assessed by measuring changes in GI Score
    Time Frame
    6,12,18,24 months
    Title
    Changes in Quality of life
    Description
    Measure of Quality of life using Short-Form 36
    Time Frame
    6, 12, 18, 24 months
    Other Pre-specified Outcome Measures:
    Title
    Resolution of Type 2 Diabetes
    Description
    Resolution rate of T2DM (based on normalized HbA1c without medication)
    Time Frame
    6,12,18,24 months
    Title
    Resolution of Hypertension
    Description
    Resolution rate of hypertension, base on normalized blood pressure without medication
    Time Frame
    6,12,18,24 months
    Title
    Resolution of dyslipidemia
    Description
    Percentage of patients with normalized cholesterol without medication
    Time Frame
    6,12,18,24 months
    Title
    Resolution of sleep apnea
    Description
    Percentage of patients with normalized sleep apnea testing without airway support
    Time Frame
    6,12,18,24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities Exclusion Criteria: BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laurent Biertho, MD
    Organizational Affiliation
    Quebec Heart and Lung Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Publication in peer-reviewed journal
    Citations:
    PubMed Identifier
    32940866
    Citation
    Malo FC, Marion A, Rioux A, Lebel S, Hould F, Julien F, Marceau S, Lescelleur O, Lafortune A, Bouvet-Bouchard L, Biertho L. Long Alimentary Limb Duodenal Switch (LADS): an Exploratory Randomized Trial, Results at 2 Years. Obes Surg. 2020 Dec;30(12):5047-5058. doi: 10.1007/s11695-020-04968-5. Epub 2020 Sep 17.
    Results Reference
    derived

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    Duodenal Switch With a Standard Versus Long Alimentary Limb

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