NCT03938571

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
32mo left

Started Aug 2016

Longer than P75 for not_applicable obesity

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2016Jan 2029

Study Start

First participant enrolled

August 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Expected
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

7.4 years

First QC Date

March 11, 2019

Last Update Submit

February 17, 2026

Conditions

ObesitySurgeryMetabolic SyndromeMalnutrition

Outcome Measures

Primary Outcomes (2)

  • Change of weight (kg)

    Change of weight in kg with calculation of the relative weight-loss under the follow-up

    January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up)

  • Early complications

    Rate of minor and major complications

    Up to 10 years after operation

Secondary Outcomes (14)

  • 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 (sleeping apnea)

    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 (protein)

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

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Duodenal Switch

Interventions

Duodenal SwitchPROCEDURE
SADI-DSStandard DS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 39042310DERIVED

MeSH Terms

Conditions

ObesityMetabolic SyndromeMalnutrition

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Bengt Hansske, M.D.

    Consultant

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

May 6, 2019

Study Start

August 1, 2016

Primary Completion

January 1, 2024

Study Completion (Estimated)

January 1, 2029

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share