Bariatric Surgery Candidate, Metabolism Disorder, Obesity, Morbid
Conditions
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.
Interventions
BPD-DS with a long strict alimentary limb and a 100-cm common channel.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total weight change | 6, 12, 18, 24 months | Changes in total body weight, in kg, from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Resolution of sleep apnea | 6,12,18,24 months | Percentage of patients with normalized sleep apnea testing without airway support |
| Resolution of dyslipidemia | 6,12,18,24 months | Percentage of patients with normalized cholesterol without medication |
| 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 |