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Active, Not Recruiting

NCT Number: NCT04219787

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity, Morbid Apnea Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clarunis University Center for Gastrointestinal and Liver Diseases

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long BPL LRYGB

Procedure

LRYGB with an 180 cm BPL and an AL of 80 cm.

Other names: LBPL LRYGB

Short BPL LRYGB

Procedure

The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Other names: SBPL LRYGB

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Clarunis - Universitäres Bauchzentrum Basel

Other

Registry information

Official study title

Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery

Acronym: SLIM

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jan 7, 2020
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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