Single Anastomosis Versus Standard Duodenal Switch

NCT04767490 | Recruiting

• 1 other identifier: SADI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Morbid Obesity

Keywords

bariatric surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Complication rate

  from baseline up to 60 months

• Cure rate of comorbidities

  from baseline up to 60 months

• Rate of minerals and vitamin deficiencies

  from baseline up to 60 months

• Body composition by bioimpedance measures

  from baseline up to 60 months

• Change in quality of life

  from baseline up to 60 months

Study Arms (2)

BPD-DS

ACTIVE COMPARATOR

Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb

Procedure: Standard Duodenal Switch

SADI

EXPERIMENTAL

Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel

Procedure: Single Anastomosis Duodenal Switch

Interventions

Standard Duodenal Switch PROCEDURE

Also known as: BPD-DS

BPD-DS

Single Anastomosis Duodenal Switch PROCEDURE

Also known as: SADI

SADI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years and ≤60 years
• Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
• Give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Biertho, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzy Laroche

CONTACT

418-656-8711; suzy_laroche@ssss.gouv.qc.ca

Mélanie Nadeau, MSc

CONTACT

418-656-8711; melanie.nadeau@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: February 23, 2021
• Study Start: September 1, 2015
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)