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

Primary Purpose

Obesity, Surgery, Metabolic Syndrome

Status

Active

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Duodenal Switch

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard DS

SADI-DS

Arm Description

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

Duodenal switch with Single anastomosis duodeno-ileostomy: Sleeve gastrectomy over a 35 Fr bougie Division of the duodenum 2-3 cm distally of the pylorus Measurement of the small bowel. 250 cm alimentary limb/common channel. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve. Closure of the mesenteric defects.

Outcomes

Primary Outcome Measures

Change of weight (kg)

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

Early complications

Rate of minor and major complications

Secondary Outcome Measures

Alterations in comorbidities (hypertension)

Changes of the metabolic profile (hypertension).

Alterations in comorbidities (diabetes)

Changes of the metabolic profile (diabetes)

Alterations in comorbidities (sleeping apnea)

Changes of the metabolic profile (sleeping apnea)

Alterations in comorbidities (hyperlipideamia)

Changes of the metabolic profile (hyperlipidemia)

Development of malnutrition (protein)

Changes of levels of protein

Development of malnutrition (vitamin A)

Changes of levels of vitamin A

Development of malnutrition (vitamin D)

Changes of levels of vitamin D

Development of malnutrition (vitamin B12)

Changes of levels of vitamin B12

Development of malnutrition (vitamin B6)

Changes of levels of vitamin B6

Development of malnutrition (vitamin B1)

Changes of levels of vitamin B1

Development of malnutrition (vitamin E)

Changes of levels of vitamin E

Development of malnutrition (calcium)

Changes of levels of calcium

Late minor complications

Rate of minor complications (Clavien Dindo < IIIB)

Late major complications

Rate of major complications (Clavien Dindo > and = IIIB)

Full Information

NCT ID

NCT03938571

First Posted

March 11, 2019

Last Updated

August 31, 2023

Sponsor

Värmland County Council, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT03938571

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2016 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Värmland County Council, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Surgery, Metabolic Syndrome, Malnutrition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard DS

Arm Type

Experimental

Arm Description

Arm Title

SADI-DS

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Duodenal Switch

Primary Outcome Measure Information:

Title

Change of weight (kg)

Description

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)

Title

Early complications

Description

Rate of minor and major complications

Time Frame

Up to 10 years after operation

Secondary Outcome Measure Information:

Title

Alterations in comorbidities (hypertension)

Description

Changes of the metabolic profile (hypertension).

Time Frame