Clinical trial NCT03097926: Duodenal Switch With a Standard Versus Long Alimentary Limb
Official title: Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Metabolism Disorder
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total weight change
timeFrame: 6, 12, 18, 24 months
Secondary outcomes:
measure: Changes in Gastro-intestinal side-effects scores
timeFrame: 6,12,18,24 months
measure: Changes in Quality of life
timeFrame: 6, 12, 18, 24 months
Other outcomes:
measure: Resolution of Type 2 Diabetes
timeFrame: 6,12,18,24 months
measure: Resolution of Hypertension
timeFrame: 6,12,18,24 months
measure: Resolution of dyslipidemia
timeFrame: 6,12,18,24 months
measure: Resolution of sleep apnea
timeFrame: 6,12,18,24 months
Locations:
Study officials:
affiliation: Quebec Heart and Lung Institute
name: Laurent Biertho, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.