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

Conditions

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

Study Locations

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.
Procedure: Long BPL LRYGB
LRYGB with an 180 cm BPL and an AL of 80 cm.
Other Names:
  • LBPL LRYGB
ACTIVE_COMPARATOR: Short Biliopancreatic Limb LRYGB
Standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Procedure: Short BPL LRYGB
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Other Names:
  • SBPL LRYGB

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.
From baseline to 5 years after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clarunis - Universitäres Bauchzentrum Basel

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.

General Publications

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

Keywords

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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