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Active, not recruitingNCT03938571Updated Feb 18, 2026

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

An interventional study of Duodenal Switch in Obesity, Surgery and Metabolic Syndrome, sponsored by Värmland County Council, Sweden. Active, not recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Värmland County Council, Sweden · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Aug 2016, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Surgery
  • Metabolic Syndrome
  • Malnutrition
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 56 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Värmland County Council, Sweden is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI over 45
  • Ability to understand the legal background of a study

Exclusion criteria

Exclusion Criteria:

  • Previous bariatric or anti-reflux surgery
  • Drug-abuse
  • Inflammatory bowel disease
  • Complex psychiatric situation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Standard DS

    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.

    Procedure: Duodenal Switch

  • Active comparator
    SADI-DS

    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.

    Procedure: Duodenal Switch

Interventions

  • ProcedureDuodenal Switch
06

What researchers measure

Primary outcomes

  1. 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)

  2. Early complications

    Rate of minor and major complications

    Time frame: Up to 10 years after operation

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Axer S, Al-Tai S, Ihle C, Hoffmann L. Five-year Outcomes After Single-Anastomosis Duodeno-Ileal Bypass (SADI) vs. Biliopancreatic Diversion with Duodenal Switch (BPD/DS): A Randomized Clinical Trial. Obes Surg. 2026 Jul;36(7):3832-3839. doi: 10.1007/s11695-026-08797-w. Epub 2026 Jun 10. PubMed 42270885 ↗
  • Axer S, Al-Tai S, Ihle C, Alwan M, Hoffmann L. Perioperative Safety and 1-Year Outcomes of Single-Anastomosis Duodeno-Ileal Bypass (SADI) vs. Biliopancreatic Diversion with Duodenal Switch (BPD/DS): A Randomized Clinical Trial. Obes Surg. 2024 Sep;34(9):3382-3389. doi: 10.1007/s11695-024-07421-z. Epub 2024 Jul 23. PubMed 39042310 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03938571
Lead sponsor
Värmland County Council, Sweden
Responsible party
Sponsor
First posted
May 6, 2019
Start date
Aug 2016
Primary completion
Jan 2024
Completion
Jan 2029 (estimated)
Last update
Feb 18, 2026

Study contacts

Bengt Hansske, M.D.
study chair · Consultant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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