- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219787
Different Limb Lengths in Gastric Bypass Surgery (SLIM)
August 11, 2020 updated by: Clarunis - Universitäres Bauchzentrum Basel
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world.
In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients.
One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB).
There is still lack of knowledge why some patients respond much better than others to an identically performed procedure.
Therefore, a number of variations of this operation have been introduced over the past 50 years.
Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies.
The metabolic effect of LRYGB occurs, in part, independently of weight loss.
The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ralph Peterli, MD, Professor
- Phone Number: +41617777501
- Email: ralph.peterli@clarunis.ch
Study Locations
-
-
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Basel, Switzerland
- Recruiting
- Clarunis University Center for Gastrointestinal and Liver Diseases
-
Contact:
- Ralph Peterli, Prof. Dr.
- Email: ralph.peterli@clarunis.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland (SMOB guidelines)
Exclusion Criteria:
- general contraindications to kind of surgery
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
- participation in another study
- age < 18 years or > 65 years
- BMI > 60 kg/m2
- height < 145 cm
- CL length of < 180 cm as measured intraoperatively
- ASA physical status classification > III
- inflammatory bowel disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Long Biliopancreatic Limb LRYGB
LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
|
LRYGB with an 180 cm BPL and an AL of 80 cm.
Other Names:
|
ACTIVE_COMPARATOR: Short Biliopancreatic Limb LRYGB
Standard LRYGB with a 80 cm BPL and a 180 cm long AL.
|
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excess BMI loss (%EBMIL)
Time Frame: From baseline to 5 years after surgery.
|
The change of percent excess BMI loss (%EBMIL) after surgery.
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From baseline to 5 years after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Marko Kraljevic, MD, Clarunis - Universitäres Bauchzentrum Basel
- Study Chair: Tarik Delko, MD, Senior Lecturer, Clarunis - Universitäres Bauchzentrum Basel
- Study Chair: Marco Bueter, MD, Professor, University Hospital Zurch
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2020
Primary Completion (ANTICIPATED)
December 31, 2026
Study Completion (ANTICIPATED)
December 31, 2026
Study Registration Dates
First Submitted
January 3, 2020
First Submitted That Met QC Criteria
January 4, 2020
First Posted (ACTUAL)
January 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 13, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-02392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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