Long_limb_DS: Duodenal Switch With a Standard Versus Long Alimentary Limb
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard BPD-DS Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel |
Procedure: Long alimentary limb BPD-DS
BPD-DS with a long strict alimentary limb and a 100-cm common channel.
|
| Experimental: 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.
|
Outcome Measures
Primary Outcome Measures
- Total weight change [6, 12, 18, 24 months]
Changes in total body weight, in kg, from baseline
Secondary Outcome Measures
- Changes in Gastro-intestinal side-effects scores [6,12,18,24 months]
Gastro-intestinal symptoms assessed by measuring changes in GI Score
- Changes in Quality of life [6, 12, 18, 24 months]
Measure of Quality of life using Short-Form 36
Other Outcome Measures
- Resolution of Type 2 Diabetes [6,12,18,24 months]
Resolution rate of T2DM (based on normalized HbA1c without medication)
- Resolution of Hypertension [6,12,18,24 months]
Resolution rate of hypertension, base on normalized blood pressure without medication
- Resolution of dyslipidemia [6,12,18,24 months]
Percentage of patients with normalized cholesterol without medication
- Resolution of sleep apnea [6,12,18,24 months]
Percentage of patients with normalized sleep apnea testing without airway support
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Laval University
Investigators
- Principal Investigator: Laurent Biertho, MD, Quebec Heart and Lung Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DS long Limb