NCT07115836Active, not recruiting
Standard Versus "Single Loop" Bypass After Parietal Gastrectomy
Standard Versus "Single Loop" Bypass After Parietal Gastrectomy: a Randomized Double-blind Study
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 4 Aug 2025
- Start date
- 6 Jan 2017
- Primary completion date
- 6 Jan 2025
- Lead sponsor
- Laval University
- Diseases
- Obesity
- NCT number
- NCT07115836
What you commit to
- Study type: Interventional
- Participants enrolled: 63
- From 6 Jan 2017 to the primary completion date, 6 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Other bariatric procedures apart from parietal gastrectomy.
- Pregnancy or desire for pregnancy within 2 years
- Intellectual retardation making consent impossible or patient under guardianship
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Criucpq-Ul Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.