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

Study Overview
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Brief Summary
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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.

Official Title
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Torsby I Trial: A Prospectively Randomized Study on Standard Duodenal Switch vs. Single Anastomosis Duodeno-ileostomy Duodenal Switch

Conditions
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Obesity, Surgery, Metabolic Syndrome, Malnutrition

Intervention / Treatment
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* Procedure: Duodenal Switch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard DS<br>Standard duodenal switch: Sleeve gastrectomy over a 35 Fr bougie Division of the duodenum 2-3 cm distally of the pylorus Measurement of the small bowel. 100 cm common channel. 150 cm alimentary limb. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. Entero-entero-anastomosis linear stapled and handsewn. Division between the two anastomosis. Closure of the mesenteric defects. | Procedure: Duodenal Switch<br> <br> |
| Active Comparator: SADI-DS<br>Duodenal switch with Single anastomosis duodeno-ileostomy: Sleeve gastrectomy over a 35 Fr bougie Division of the duodenum 2-3 cm distally of the pylorus Measurement of the small bowel. 250 cm alimentary limb/common channel. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. Closure of the mesenteric defects. | Procedure: Duodenal Switch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of weight (kg) | Change of weight in kg with calculation of the relative weight-loss under the follow-up | January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up) | 
| Early complications | Rate of minor and major complications | Up to 10 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in comorbidities (hypertension) | Changes of the metabolic profile (hypertension). | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Alterations in comorbidities (diabetes) | Changes of the metabolic profile (diabetes) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Alterations in comorbidities (sleeping apnea) | Changes of the metabolic profile (sleeping apnea) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Alterations in comorbidities (hyperlipideamia) | Changes of the metabolic profile (hyperlipidemia) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (protein) | Changes of levels of protein | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (vitamin A) | Changes of levels of vitamin A | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (vitamin D) | Changes of levels of vitamin D | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (vitamin B12) | Changes of levels of vitamin B12 | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (vitamin B6) | Changes of levels of vitamin B6 | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (vitamin B1) | Changes of levels of vitamin B1 | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (vitamin E) | Changes of levels of vitamin E | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Development of malnutrition (calcium) | Changes of levels of calcium | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Late minor complications | Rate of minor complications (Clavien Dindo < IIIB) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | 
| Late major complications | Rate of major complications (Clavien Dindo > and = IIIB) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) |