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

• Sponsor: Värmland County Council, Sweden (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03938571
• Collaborator: (none)
• Enrollment: 56
• Arms: 2
• Anticipated Duration (Months): 149

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Surgery; Metabolic Syndrome; Malnutrition	Procedure: Duodenal Switch	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Torsby I Trial: A Prospectively Randomized Study on Standard Duodenal Switch vs. Single Anastomosis Duodeno-ileostomy Duodenal Switch
• Actual Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard DS Standard duodenal switch: Sleeve gastrectomy over a 35 Fr bougie Division of the duodenum 2-3 cm distally of the pylorus Measurement of the small bowel. 100 cm common channel. 150 cm alimentary limb. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. Entero-entero-anastomosis linear stapled and handsewn. Division between the two anastomosis. Closure of the mesenteric defects.	Procedure: Duodenal Switch
Active Comparator: SADI-DS Duodenal switch with Single anastomosis duodeno-ileostomy: Sleeve gastrectomy over a 35 Fr bougie Division of the duodenum 2-3 cm distally of the pylorus Measurement of the small bowel. 250 cm alimentary limb/common channel. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. Closure of the mesenteric defects.	Procedure: Duodenal Switch

Outcome Measures

Primary Outcome Measures

1. 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

2. Early complications [Up to 10 years after operation]

   Rate of minor and major complications

Secondary Outcome Measures

1. 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).

2. 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)

3. 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)

4. 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)

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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)

14. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Värmland County Council, Sweden

Investigators

• Study Chair: Bengt Hansske, M.D., Consultant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Värmland County Council, Sweden
• ClinicalTrials.gov Identifier: NCT03938571
• Other Study ID Numbers: 2016/133
• First Posted: May 6, 2019
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Malnutrition

Study Results

No Results Posted as of Jun 28, 2022