Obesity, Surgery, Metabolic Syndrome, Malnutrition
Conditions
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.
Interventions
PROCEDUREDuodenal Switch
Sponsors
Värmland County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of weight (kg) | January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up) | Change of weight in kg with calculation of the relative weight-loss under the follow-up |
| Early complications | Up to 10 years after operation | Rate of minor and major complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alterations in comorbidities (hypertension) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of the metabolic profile (hypertension). |
| Alterations in comorbidities (diabetes) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of the metabolic profile (diabetes) |
| Alterations in comorbidities (sleeping apnea) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of the metabolic profile (sleeping apnea) |
| Alterations in comorbidities (hyperlipideamia) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of the metabolic profile (hyperlipidemia) |
| Development of malnutrition (protein) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of protein |
| Development of malnutrition (vitamin A) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of vitamin A |
| Development of malnutrition (vitamin D) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of vitamin D |
| Development of malnutrition (vitamin B12) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of vitamin B12 |
| Development of malnutrition (vitamin B6) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of vitamin B6 |
| Development of malnutrition (vitamin B1) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of vitamin B1 |
| Development of malnutrition (vitamin E) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of vitamin E |
| Development of malnutrition (calcium) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Changes of levels of calcium |
| Late minor complications | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Rate of minor complications (Clavien Dindo \< IIIB) |
| Late major complications | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) | Rate of major complications (Clavien Dindo \> and = IIIB) |
Contacts
STUDY_CHAIRBengt Hansske, M.D.
Consultant
Outcome results
None listed