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Clinical Trials/NCT03938571
NCT03938571Active, not recruitingNot Applicable

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

Värmland County Council, Sweden0 sites56 target enrollmentStarted: August 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
56
Primary Endpoint
Change of weight (kg)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Standard DS

Experimental

Standard duodenal switch:

  1. Sleeve gastrectomy over a 35 Fr bougie
  2. Division of the duodenum 2-3 cm distally of the pylorus
  3. Measurement of the small bowel. 100 cm common channel. 150 cm alimentary limb.
  4. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve.
  5. Entero-entero-anastomosis linear stapled and handsewn.
  6. Division between the two anastomosis.
  7. Closure of the mesenteric defects.

Intervention: Duodenal Switch (Procedure)

SADI-DS

Active Comparator

Duodenal switch with Single anastomosis duodeno-ileostomy:

  1. Sleeve gastrectomy over a 35 Fr bougie
  2. Division of the duodenum 2-3 cm distally of the pylorus
  3. Measurement of the small bowel. 250 cm alimentary limb/common channel.
  4. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve.
  5. Closure of the mesenteric defects.

Intervention: Duodenal Switch (Procedure)

Outcomes

Primary Outcomes

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

Early complications

Time Frame: Up to 10 years after operation

Rate of minor and major complications

Secondary Outcomes

  • Alterations in comorbidities (hypertension)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Alterations in comorbidities (diabetes)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Alterations in comorbidities (hyperlipideamia)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin D)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Alterations in comorbidities (sleeping apnea)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (protein)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin A)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin B6)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin B1)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Late minor complications(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin B12)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin E)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (calcium)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Late major complications(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))

Investigators

Sponsor
Värmland County Council, Sweden
Sponsor Class
Other Gov
Responsible Party
Sponsor

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