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Different Limb Lengths in Gastric Bypass Surgery (SLIM)

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ClinicalTrials.gov Identifier: NCT04219787
Recruitment Status : Active, not recruiting
First Posted : January 7, 2020
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Clarunis - Universitäres Bauchzentrum Basel

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Diabetes Mellitus, Type 2 Hypertension Dyslipidemias Sleep Apnea Procedure: Long BPL LRYGB Procedure: Short BPL LRYGB Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 30, 2028
Estimated Study Completion Date : November 30, 2028
Arms and Interventions
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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 Name: 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 Name: SBPL LRYGB


Outcome Measures
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Primary Outcome Measures :
  1. Primary endpoint [ Time Frame: From baseline to 5 years after surgery. ]
    Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).


Secondary Outcome Measures :
  1. Secondary endpoints [ Time Frame: From baseline to 5 years after surgery. ]
    Percent excess body mass index loss (%EBMIL), remission of comorbidities, complication rate/safety, and quality of life 1, 3, and 5 years after long and short BPL RYGB.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent as documented by signature
  • patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219787


Locations
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Switzerland
Clarunis University Center for Gastrointestinal and Liver Diseases
Basel, Switzerland
Sponsors and Collaborators
Clarunis - Universitäres Bauchzentrum Basel
Investigators
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Study Chair: Marko Kraljevic, MD Clarunis - Universitäres Bauchzentrum Basel
Study Chair: Marco Bueter, MD, Professor University Hospital Zurch
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clarunis - Universitäres Bauchzentrum Basel
ClinicalTrials.gov Identifier: NCT04219787    
Other Study ID Numbers: 2019-02392
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clarunis - Universitäres Bauchzentrum Basel:
Roux-en-Y Gastric Bypass
Biliopancreatic Limb Length
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Dyslipidemias
Obesity, Morbid
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Lipid Metabolism Disorders
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight