Duodenal Switch With a Standard Versus Long Alimentary Limb
Long_limb_DS
Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 27, 2018
March 1, 2018
4.8 years
January 2, 2017
March 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Total weight change
Changes in total body weight, in kg, from baseline
6, 12, 18, 24 months
Secondary Outcomes (2)
Changes in Gastro-intestinal side-effects scores
6,12,18,24 months
Changes in Quality of life
6, 12, 18, 24 months
Other Outcomes (4)
Resolution of Type 2 Diabetes
6,12,18,24 months
Resolution of Hypertension
6,12,18,24 months
Resolution of dyslipidemia
6,12,18,24 months
- +1 more other outcomes
Study Arms (2)
Standard BPD-DS
ACTIVE COMPARATORStandard BPD-DS with a 250-cm alimentary limb and 100-cm common channel
Long alimentary limb BPD-DS
EXPERIMENTALBPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel
Interventions
BPD-DS with a long strict alimentary limb and a 100-cm common channel.
Eligibility Criteria
You may qualify if:
- Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities
You may not qualify if:
- BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Related Publications (1)
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.
PMID: 32940866DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Biertho, MD
Quebec Heart and Lung Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 2, 2017
First Posted
March 31, 2017
Study Start
May 1, 2013
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 27, 2018
Record last verified: 2018-03