Single Anastomosis Versus Standard Duodenal Switch
Obesity | Morbid ObesityBilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion.
Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.
The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 to 60
Participation Criteria
Inclusion Criteria:
* Age ≥18 years and ≤60 years
* Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
* Give written informed consent
Exclusion Criteria:
Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
* Presence of the following baseline comorbidities:
* Inflammatory bowel disease (IBD),
* Cirrhosis
* History of gastric or duodenal ulcers
* Preoperative hypoalbuminemia (\<35 g/L)
* History of severe renal, hepatic, cardiac or pulmonary disease
* Past esophageal, gastric or bariatric surgery
* Type 1 Diabetes
* Pregnancy
* Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations
* History of drug use or alcohol abuse in the last 6 months
* History of gastro-intestinal inflammatory diseases
Study Location
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuebec City, Quebec
Canada
Contact Study Team
- Study Sponsored By
- Laval University
- Participants Required
- More Information
- Study ID:
NCT04767490