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
About this trial
This is an interventional treatment trial for Obesity, Morbid
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.
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
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
Learn more about this trial
Duodenal Switch With a Standard Versus Long Alimentary Limb
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