Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

NCT07115836 | Active Not Recruiting

• 1 other identifier: Second stage SADI, pilot study
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Keywords

Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Weight loss

  % Excess weights loss

  from baseline to 60 months

Secondary Outcomes (14)

• Mortality rate

  from baseline to 60 months

• Early complications

  from baseline to 30 days

• Late complications

  from 30 days to 60 months

• Operating time

  baseline

• Blood loss

  baseline

Study Arms (2)

Biliopancreatic diversion with duodenal switch

ACTIVE COMPARATOR

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

Procedure: Standard duodenal switch

Single-anastomosis duodenal-ileal anastomosis

EXPERIMENTAL

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

Procedure: Single-anastomosis duodenal switch

Interventions

Standard duodenal switch PROCEDURE

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

Biliopancreatic diversion with duodenal switch

Single-anastomosis duodenal switch PROCEDURE

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

Single-anastomosis duodenal-ileal anastomosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Fondation de l'Institut universitaire de cardiologie et pneumologie de Québec: collaborator

Study Sites (1)

Criucpq-Ul

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: This is a single-center double-blind randomized trial

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: January 6, 2017
• Primary Completion: January 6, 2025
• Study Completion (Estimated): January 6, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CA (1)