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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03938571
• Other study ID #: 2016/133
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2029

Study information

• Verified date: August 2023
• Source: Värmland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: January 2029
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Metabolic Syndrome
• Obesity
• Surgery

Intervention

Procedure:
• Duodenal Switch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Värmland County Council, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Early complications	Rate of minor and major complications	Up to 10 years after operation
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)