Recruiting

Single Anastomosis vs. Standard

Sponsor:

Laval University

Code:

NCT04767490

Conditions

Obesity

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Standard Duodenal Switch

Single Anastomosis Duodenal Switch

Study Details

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

Study ID

NCT04767490

Start date

Sep 1, 2015

Status verified date

Aug, 2024

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BPD-DS

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

experimental: SADI

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

Interventions

Standard Duodenal Switch

Single Anastomosis Duodenal Switch

Primary outcome measure

  • Excess weight loss [ Time Frame: 2 years ]
  • Rate of protein deficiency or insufficiency [ Time Frame: from baseline up to 60 months ]
  • Mortality rate [ Time Frame: from baseline up to 60 months ]
  • BMI [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Suzy Laroche

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

Mélanie Nadeau, MSc

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

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Quebec City, Quebec, Canada, G1V 4G5

Contacts

Suzy Laroche

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

Principal Investigator:

Laurent Biertho, MD

More Information

Sponsor

Laval University

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

  • bariatric surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2024-08-09.