Standard Versus "Single Loop" Bypass After Parietal Gastrectomy

Laval University

Status: Active, not recruiting

Conditions: Obesity; Obesity, Morbid

Treatments: Procedure: Single-anastomosis duodenal switch; Procedure: Standard duodenal switch

Study type: Interventional

Funder types: Other

Identifiers

NCT07115836

Second stage SADI, pilot study

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups

Biliopancreatic diversion with duodenal switch

Active Comparator group

Description:

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

Treatment:

Procedure: Standard duodenal switch

Single-anastomosis duodenal-ileal anastomosis

Experimental group

Description:

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

Treatment:

Procedure: Single-anastomosis duodenal switch