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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard DS | Experimental | Standard duodenal switch:
|
|
| SADI-DS | Active Comparator | Duodenal switch with Single anastomosis duodeno-ileostomy:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duodenal Switch | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in comorbidities (hypertension) | Changes of the metabolic profile (hypertension). | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) |
| Alterations in comorbidities (diabetes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bengt Hansske, M.D. | Consultant | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42270885 | Derived | 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 Jun 10. doi: 10.1007/s11695-026-08797-w. Online ahead of print. | |
| 39042310 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Changes of the metabolic profile (diabetes)
| 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |