NCT07115836

Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

Standard Versus "Single Loop" Bypass After Parietal Gastrectomy: a Randomized Double-blind Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-01-06
• Primary completion: 2025-01-06
• Completion: 2028-01-06
• First posted: 2025-08-11
• Last updated: 2025-12-08

Locations

1 site across 1 country: Canada