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Active, Not Recruiting

NCT Number: NCT03938571

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Malnutrition Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duodenal Switch

Procedure

Primary outcomes

  1. Change of weight (kg)

    Time frame: 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

  2. Early complications

    Time frame: Up to 10 years after operation

    Rate of minor and major complications

Secondary outcomes

  1. Alterations in comorbidities (hypertension)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of the metabolic profile (hypertension).

  2. Alterations in comorbidities (diabetes)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of the metabolic profile (diabetes)

  3. Alterations in comorbidities (sleeping apnea)

    Time frame: 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)

  4. Alterations in comorbidities (hyperlipideamia)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of the metabolic profile (hyperlipidemia)

  5. Development of malnutrition (protein)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of protein

  6. Development of malnutrition (vitamin A)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of vitamin A

  7. Development of malnutrition (vitamin D)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of vitamin D

  8. Development of malnutrition (vitamin B12)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of vitamin B12

  9. Development of malnutrition (vitamin B6)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of vitamin B6

  10. Development of malnutrition (vitamin B1)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of vitamin B1

  11. Development of malnutrition (vitamin E)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of vitamin E

  12. Development of malnutrition (calcium)

    Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)

    Changes of levels of calcium

  13. Late minor complications

    Time frame: 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)

  14. Late major complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Värmland County Council, Sweden

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2029
First posted
May 6, 2019
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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