Clinical trial NCT03938571: Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch
Official title: Torsby I Trial: A Prospectively Randomized Study on Standard Duodenal Switch vs. Single Anastomosis Duodeno-ileostomy Duodenal Switch
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Surgery
Metabolic Syndrome
Malnutrition
Lead sponsor: Värmland County Council, Sweden
Sponsor class: OTHER_GOV
First posted: 2019-05-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of weight (kg)
timeFrame: January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up)
measure: Early complications
timeFrame: Up to 10 years after operation
Secondary outcomes:
measure: Alterations in comorbidities (hypertension)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Alterations in comorbidities (diabetes)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Alterations in comorbidities (sleeping apnea)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Alterations in comorbidities (hyperlipideamia)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (protein)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (vitamin A)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (vitamin D)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (vitamin B12)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (vitamin B6)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (vitamin B1)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (vitamin E)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Development of malnutrition (calcium)
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Late minor complications
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
measure: Late major complications
timeFrame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: Consultant
name: Bengt Hansske, M.D.
role: STUDY_CHAIR
References: