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Different Limb Lengths in Gastric Bypass Surgery (SLIM)

Primary Purpose

Obesity, Morbid, Diabetes Mellitus, Type 2, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Long BPL LRYGB
Short BPL LRYGB
Sponsored by
Clarunis - Universitäres Bauchzentrum Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Roux-en-Y Gastric Bypass, Biliopancreatic Limb Length

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clarunis University Center for Gastrointestinal and Liver DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long Biliopancreatic Limb LRYGB

Short Biliopancreatic Limb LRYGB

Arm Description

LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.

Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Outcomes

Primary Outcome Measures

Excess BMI loss (%EBMIL)
The change of percent excess BMI loss (%EBMIL) after surgery.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2020
Last Updated
August 11, 2020
Sponsor
Clarunis - Universitäres Bauchzentrum Basel
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1. Study Identification

Unique Protocol Identification Number
NCT04219787
Brief Title
Different Limb Lengths in Gastric Bypass Surgery
Acronym
SLIM
Official Title
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarunis - Universitäres Bauchzentrum Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Sleep Apnea
Keywords
Roux-en-Y Gastric Bypass, Biliopancreatic Limb Length

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long Biliopancreatic Limb LRYGB
Arm Type
Experimental
Arm Description
LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
Arm Title
Short Biliopancreatic Limb LRYGB
Arm Type
Active Comparator
Arm Description
Standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Intervention Type
Procedure
Intervention Name(s)
Long BPL LRYGB
Other Intervention Name(s)
LBPL LRYGB
Intervention Description
LRYGB with an 180 cm BPL and an AL of 80 cm.
Intervention Type
Procedure
Intervention Name(s)
Short BPL LRYGB
Other Intervention Name(s)
SBPL LRYGB
Intervention Description
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Primary Outcome Measure Information:
Title
Excess BMI loss (%EBMIL)
Description
The change of percent excess BMI loss (%EBMIL) after surgery.
Time Frame
From baseline to 5 years after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Peterli, MD, Professor
Phone
+41617777501
Email
ralph.peterli@clarunis.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Kraljevic, MD
Organizational Affiliation
Clarunis - Universitäres Bauchzentrum Basel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tarik Delko, MD, Senior Lecturer
Organizational Affiliation
Clarunis - Universitäres Bauchzentrum Basel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Bueter, MD, Professor
Organizational Affiliation
University Hospital Zurch
Official's Role
Study Chair
Facility Information:
Facility Name
Clarunis University Center for Gastrointestinal and Liver Diseases
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Peterli, Prof. Dr.
Email
ralph.peterli@clarunis.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34011386
Citation
Kraljevic M, Schneider R, Wolnerhanssen B, Bueter M, Delko T, Peterli R. Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM). Trials. 2021 May 19;22(1):352. doi: 10.1186/s13063-021-05313-6.
Results Reference
derived

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Different Limb Lengths in Gastric Bypass Surgery

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