An interventional study of Long alimentary limb BPD-DS in Obesity, Morbid, Bariatric Surgery Candidate and Metabolism Disorder, sponsored by Laval University. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
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.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's enrollment of 20 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel
Procedure: Long alimentary limb BPD-DS
BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel
Procedure: Long alimentary limb BPD-DS
BPD-DS with a long strict alimentary limb and a 100-cm common channel.
Total weight change
Changes in total body weight, in kg, from baseline
Time frame: 6, 12, 18, 24 months
Changes in Gastro-intestinal side-effects scores
Gastro-intestinal symptoms assessed by measuring changes in GI Score
Time frame: 6,12,18,24 months
Changes in Quality of life
Measure of Quality of life using Short-Form 36
Time frame: 6, 12, 18, 24 months
Resolution of Type 2 Diabetes
Resolution rate of T2DM (based on normalized HbA1c without medication)
Time frame: 6,12,18,24 months
Resolution of Hypertension
Resolution rate of hypertension, base on normalized blood pressure without medication
Time frame: 6,12,18,24 months
Resolution of dyslipidemia
Percentage of patients with normalized cholesterol without medication
Time frame: 6,12,18,24 months
Resolution of sleep apnea
Percentage of patients with normalized sleep apnea testing without airway support
Time frame: 6,12,18,24 months
No study locations are listed for this record.
Plan to share: Undecided — Publication in peer-reviewed journal
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Laval University