Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

NCT ID: NCT07115836

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2028-01-06

Brief 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

Obesity, Morbid; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Biliopancreatic diversion with duodenal switch

Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)

Group Type: ACTIVE_COMPARATOR

Standard duodenal switch

Intervention Type: PROCEDURE

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

Single-anastomosis duodenal-ileal anastomosis

Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Group Type: EXPERIMENTAL

Single-anastomosis duodenal switch

Intervention Type: PROCEDURE

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

Interventions

Standard duodenal switch

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

Intervention Type: PROCEDURE

Single-anastomosis duodenal switch

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who had a parietal gastrectomy more than 18 months ago and
• Who still meet NIH criteria for bariatric surgery (BMI ≥ 35kg/m2 with associated disease or BMI ≥ 40kg/m2) or
• Have lost < 50% of their excess weight, or
• Have significant weight regain (≥ 20% EWL)
• Accepting long-term care and follow-up and willing to participate in this study after informed consent

Exclusion Criteria

• Other bariatric procedures apart from parietal gastrectomy.
• Psychiatric illness not stabilized for more than 6 months
• Severe illness with life-threatening consequences within 5 years
• Diagnosis of cancer within the last 3 years
• Chronic digestive disorders (chronic diarrhea, inflammatory diseases, cirrhosis, intestinal resections, functional abdominal pain)
• Pregnancy or desire for pregnancy within 2 years
• Intellectual retardation making consent impossible or patient under guardianship

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Laurent Biertho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Criucpq-Ul

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

Second stage SADI, pilot study

Identifier Type: -

Identifier Source: org_study_id