ObesityNCT03938571
Standard Duodenal Switch vs. Single Anastomosis Duodeno-Ileostomy Duodenal Switch
A study testing Duodenal Switch in people with Obesity and Surgery, run by Värmland County Council, Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Surgery, Metabolic Syndrome
- What is being tested?
- Duodenal Switch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI over 45
- Ability to understand the legal background of a study
Who cannot join
- Previous bariatric or anti-reflux surgery
- Drug-abuse
- Inflammatory bowel disease
- Complex psychiatric situation
About this study
Official title: Torsby I Trial: A Prospectively Randomized Study on 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.
- Conditions
- Obesity, Surgery, Metabolic Syndrome, Malnutrition
- Being tested
- Duodenal Switch
- Medical subject headings
- Obesity, Metabolic Syndrome, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal SwitchProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Duodenal Switch |
| 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. Receives: Procedure: Duodenal Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of weight (kg)
Change of weight in kg with calculation of the relative weight-loss under the follow-up
Measured: January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up)
Early complications
Rate of minor and major complications
Measured: Up to 10 years after operation
Secondary outcomes (14)
Alterations in comorbidities (hypertension)
Changes of the metabolic profile (hypertension).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Development of malnutrition (vitamin A)
Changes of levels of vitamin A
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study startAug 2016
- Primary completionJan 2024
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bengt Hansske, M.D., Study chair, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938571
- Sponsor's protocol ID
- 2016/133
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2019
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 42270885Axer 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Torsby I Trial: A Prospectively Randomized Study on Standard Duodenal Switch vs. Single Anastomosis Duodeno-ileostomy Duodenal Switch
- ClinicalTrials.gov ID
- NCT03938571
- Acronym / sponsor ID
- 2016/133
- Conditions
- Obesity, Surgery, Metabolic Syndrome, Malnutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2024 (actual)
- Study completion
- Jan 2029 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard DS | Experimental | Procedure: Duodenal SwitchStandard 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. |
| SADI-DS | Active comparator | Procedure: Duodenal SwitchDuodenal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI over 45
- Ability to understand the legal background of a study
Key exclusion criteria (4 listed)
- Previous bariatric or anti-reflux surgery
- Drug-abuse
- Inflammatory bowel disease
- Complex psychiatric situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duodenal Switch | Procedure or surgery | SADI-DS, Standard DS |
Primary outcome
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
14 secondary outcomes
Alterations in comorbidities (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)
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)
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Alterations in comorbidities (hyperlipideamia)
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Development of malnutrition (protein)
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
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)
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)
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)
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)
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)
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)
Development of malnutrition (calcium)
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Late minor complications
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Late major complications
Time frame: January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 42270885Axer 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.
- Derived from this study: PubMed 39042310Axer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Hansske, M.D. study chair
Consultant
Questions about this trial
What is this clinical trial studying?
A study testing Duodenal Switch in people with Obesity and Surgery, run by Värmland County Council, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of weight (kg) (time frame: January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.