Single Anastomosis Versus Standard Duodenal Switch (SADI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Morbid Obesity
• Intervention / Treatment: Procedure: Standard Duodenal Switch; Procedure: Single Anastomosis Duodenal Switch

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • Recruiting
      • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Principal Investigator: Laurent Biertho, MD
      • Sub-Investigator: Simon Marceau, MD
      • Sub-Investigator: Simon Biron, MD
      • Sub-Investigator: Stéfane Lebel, MD
      • Sub-Investigator: François Julien, MD
      • Sub-Investigator: Odette Lescelleur, MD
      • Sub-Investigator: André Tchernof, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BPD-DS; Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb	Procedure: Standard Duodenal Switch; Other Names: BPD-DS
Experimental: SADI; Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel	Procedure: Single Anastomosis Duodenal Switch; Other Names: SADI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of protein deficiency or insufficiency	Rate of protein deficiency (<35gr/l) or insufficiency (<30gr/l)	from baseline up to 60 months
Mortality rate	Rate of mortality	from baseline up to 60 months
BMI	change in BMI at 2 years follow-up as compared to preoperative reference values	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	overall and surgery-specific complications	from baseline up to 60 months
Cure rate of comorbidities	Remission rate for comorbidities, including T2D, Hypertension, dyslipidemia, sleep apnea	from baseline up to 60 months
Rate of minerals and vitamin deficiencies	Rate of deficiency and insufficiency in mineral and vitamins	from baseline up to 60 months
Body composition by bioimpedance measures	body fat composition (%) assessed by biompedance	from baseline up to 60 months
Change in quality of life	36-item short form survey score from 0 to 100	from baseline up to 60 months
Change in quality of life	Bariatric Analysis and Reporting Outcomes System score from -7 to 9	from baseline up to 60 months
Change in quality of life	Laval Questionnaire score from 0 to 7	from baseline up to 60 months
Change in quality of life	GastroIntestinal Quality of Life Index from 0 to 144	from baseline up to 60 months
Change in gatroesophageal reflux symptom	GastroEsophageal Reflus Disease Score from 0 to 72	from baseline to 60 months

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Investigators: Principal Investigator: Laurent Biertho, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: bariatric surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: SADI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No