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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Change of weight (kg)
Change of weight in kg with calculation of the relative weight-loss under the follow-up
Time frame: January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up)
Early complications
Rate of minor and major complications
Time frame: Up to 10 years after operation
Alterations in comorbidities (hypertension)
Changes of the metabolic profile (hypertension).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Development of malnutrition (vitamin A)
Changes of levels of vitamin A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)