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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard BPD-DS | Active Comparator | Standard BPD-DS with a 250-cm alimentary limb and 100-cm common channel |
|
| Long alimentary limb BPD-DS | Experimental | BPD-DS with a 100-cm common channel, a 100-cm biliary limb, the remaining bowel as the strict alimentary channel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long alimentary limb BPD-DS | Procedure | BPD-DS with a long strict alimentary limb and a 100-cm common channel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total weight change | Changes in total body weight, in kg, from baseline | 6, 12, 18, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gastro-intestinal side-effects scores | Gastro-intestinal symptoms assessed by measuring changes in GI Score | 6,12,18,24 months |
| Changes in Quality of life | Measure of Quality of life using Short-Form 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Type 2 Diabetes | Resolution rate of T2DM (based on normalized HbA1c without medication) | 6,12,18,24 months |
| Resolution of Hypertension | Resolution rate of hypertension, base on normalized blood pressure without medication |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Biertho, MD | Quebec Heart and Lung Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32940866 | Derived | 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. |
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Publication in peer-reviewed journal
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 6, 12, 18, 24 months |
| 6,12,18,24 months |
| Resolution of dyslipidemia | Percentage of patients with normalized cholesterol without medication | 6,12,18,24 months |
| Resolution of sleep apnea | Percentage of patients with normalized sleep apnea testing without airway support | 6,12,18,24 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |