Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch

Värmland County Council, Sweden

Status: Active, not recruiting

Conditions: Malnutrition; Surgery; Obesity; Metabolic Syndrome

Treatments: Procedure: Duodenal Switch

Study type: Interventional

Funder types: Other

Identifiers

NCT03938571

2016/133

Details and patient eligibility

About

The aim of the Torsby I Trial is to identify differences and similarities between a standard duodenal switch (DS) and a single-anastomosis duodeno-ileostomy (SADI) regarding effect on weight, comorbidities and malnutrition.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI over 45
• Ability to understand the legal background of a study

Exclusion criteria

• Previous bariatric or anti-reflux surgery
• Drug-abuse
• Inflammatory bowel disease
• Complex psychiatric situation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Standard DS

Experimental group

Description:

Standard duodenal switch: 1. Sleeve gastrectomy over a 35 Fr bougie 2. Division of the duodenum 2-3 cm distally of the pylorus 3. Measurement of the small bowel. 100 cm common channel. 150 cm alimentary limb. 4. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. 5. Entero-entero-anastomosis linear stapled and handsewn. 6. Division between the two anastomosis. 7. Closure of the mesenteric defects.

Treatment:

Procedure: Duodenal Switch

SADI-DS

Active Comparator group

Description:

Duodenal switch with Single anastomosis duodeno-ileostomy: 1. Sleeve gastrectomy over a 35 Fr bougie 2. Division of the duodenum 2-3 cm distally of the pylorus 3. Measurement of the small bowel. 250 cm alimentary limb/common channel. 4. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. 5. Closure of the mesenteric defects.

Treatment:

Procedure: Duodenal Switch