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Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

NCT07115836 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-12-08

No results posted yet for this study

Summary

Bilio-pancreatic bypass (BPD-DS) is the most effective type of bariatric surgery in terms of weight loss and treatment of obesity-related comorbidities such as type 2 diabetes. Nevertheless, the spread of this procedure is limited by the technical difficulties and long-term nutritional complications inherent in this operation.

Recently, a simplified "Duodenal Switch" technique has been proposed. This technique is known as "Single Anastomosis Duodeno-Ileal bypass" (SADI) and involves connecting the duodenum to the ileum, 250 cm upstream of the ileo-caecal valve, via an "omega" loop. This surgery is technically simpler and possibly less risky (particularly from a nutritional point of view) than the "standard" technique developed at the IUCPQ. This explains the enthusiasm in the surgical community for SADI, although the scientific evidence is very limited. The investigator has therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery.

In this study, the investigator aims to evaluate the results of SADI versus standard bypass, as 2nd-stage surgery after parietal gastrectomy.

The hypothesis is that SADI will be accompanied by fewer digestive and nutritional side effects, but also by a lower weight loss and a lower rate of recovery from comorbidities.

Conditions

Interventions

PROCEDURE

Standard duodenal switch

Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

PROCEDURE

Single-anastomosis duodenal switch

Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Sponsors & Collaborators

  • Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec

    collaborator UNKNOWN

  • Laval University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2025-01-06
Completion
2028-01-06

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115836 on ClinicalTrials.gov