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

Not Applicable

Active, not recruiting

• Conditions: Obesity, Morbid; Obesity

• Registration Number: NCT07115836
• Lead Sponsor: Laval University

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. We have therefore initiated a prospective randomized study to compare standard bypass with single loop bypass as primary surgery.

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

Our 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-06
• Primary Completion: 2025-01-06
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Completion: 2028-01-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss	from baseline to 60 months	% Excess weights loss

Secondary Outcome Measures

Name	Time	Method
Mortality rate	from baseline to 60 months	Mortality rate
Early complications	from baseline to 30 days	Complication (≤30 days) graded with Clavien classification
Late complications	from 30 days to 60 months	Complication (\>30 days to 60 months) ga=raded with Clavien classification
Operating time	baseline	Operating time in minutes
Blood loss	baseline	Peroperative blood loss (ml) as reported in the operating room
Hospital stay	baseline	length of hospital stay (days)
Change in quality of life (QLaval)	from baseline to 60 months	Change in quality of life assessed by the Laval questionnaire evaluating 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life
Change in quality of life (SF36)	from baseline to 60 months	change in quality of life assessed with the 36-item short form survey evaluating quality of life on a scale form 0 to 100, higher scores indicate better quality of life
Digestive side effects (GERD)	from baseline to 60 months	Evaluation of gastro-oesophageal reflux symptoms using the GERD Score questionnaire, on a scale from 0 to 72, higher scores indicating greater symptoms
Digestive side effects (LARS)	baseline to 60 months	Evaluation of bowel function using the LARS questionnaire, on a scale from 0 to 42, with higher scores indicating greater symptoms
Digestive side effect (Laval digestive problems evaluation questionnaire)	from baseline to 60 months	Evaluation of digestive side effect using the Laval digestive problems evaluation questionnaire
Malnutrition rate	from baseline to 60 months	Malnutrition rate using albuminemia (mild 30-34.9g/L; moderate 25-29.9g/L; severe \<25g/L)
Nutrient deficiency rate	from baseline to 60 months	Nutrient deficiency rate based on blood analysis of vitamine A, vitamin D, vitamin B12, Calcium, magnsium, phosphorus, iron, ferritin, TIBC and parathormone and the required dose of supplements
Resolution of associated comorbidities	from baseline to 60 months	Type 2 diabetes, hypertension, sleep apnea and dislipidemia resolution and improvement according to the ASMBS criteria

Trial Locations

Locations (1)

Criucpq-Ul; 🇨🇦 Quebec City, Quebec, Canada