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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Metabolic Syndrome; Malnutrition; Surgery
• Intervention / Treatment: Procedure: Duodenal Switch

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard DS; 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
Active Comparator: SADI-DS; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Värmland County Council, Sweden
• Investigators: Study Chair: Bengt Hansske, M.D., Consultant

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nutrition Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Malnutrition
• Other Study ID Numbers: 2016/133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No