Single Anastomosis Versus Standard Duodenal Switch

Obesity Clinical Trial

— SADI  

Official title:

Single Anastomosis Versus Standard Duodenal Switch - a Prospective Randomized Single-blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04767490
• Other study ID #: SADI
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2021
• Source: Laval University
• Contact: Suzy Laroche
• Phone: 418-656-8711
• Email: suzy_laroche[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bilio-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.

Description:

Bilio-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. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.

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.

This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.

However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.

Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.

The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Standard Duodenal Switch

• Single Anastomosis Duodenal Switch

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss	Excess weight loss at 2 years of follow-up; %EWL (Excess weight loss based on an ideal BMI = 25.) and change in BMI as compared to preoperative reference values	2 years
Primary	Rate of protein deficiency or insufficiency	Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l)	from baseline up to 60 months
Primary	Mortality rate	Rate of mortality	from baseline up to 60 months
Primary	BMI	change in BMI at 2 years follow-up as compared to preoperative reference values	2 years
Secondary	Complication rate	overall and surgery-specific complications	from baseline up to 60 months
Secondary	Cure rate of comorbidities	Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea	from baseline up to 60 months
Secondary	Rate of minerals and vitamin deficiencies	Rate of deficiency and insufficiency in mineral and vitamins	from baseline up to 60 months
Secondary	Body composition by bioimpedance measures	body fat composition (%) assessed by biompedance	from baseline up to 60 months
Secondary	Change in quality of life	36-item short form survey score from 0 to 100	from baseline up to 60 months
Secondary	Change in quality of life	Bariatric Analysis and Reporting Outcomes System score from -7 to 9	from baseline up to 60 months
Secondary	Change in quality of life	Laval Questionnaire score from 0 to 7	from baseline up to 60 months
Secondary	Change in quality of life	GastroIntestinal Quality of Life Index from 0 to 144	from baseline up to 60 months
Secondary	Change in gatroesophageal reflux symptom	GastroEsophageal Reflus Disease Score from 0 to 72	from baseline to 60 months