Different Limb Lengths in Gastric Bypass Surgery

Not Applicable

Active, not recruiting

• Conditions: Obesity, Morbid; Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias; Sleep Apnea
• Interventions: Procedure: Long BPL LRYGB; Procedure: Short BPL LRYGB

• Registration Number: NCT04219787
• Lead Sponsor: Clarunis - Universitäres Bauchzentrum Basel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Study Start: 2020-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long Biliopancreatic Limb LRYGB	Long BPL LRYGB	LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
Short Biliopancreatic Limb LRYGB	Short BPL LRYGB	Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Primary Outcome Measures

Name	Time	Method
Primary endpoint	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

Name	Time	Method
Secondary endpoints	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.

Trial Locations

Locations (1)

Clarunis University Center for Gastrointestinal and Liver Diseases; 🇨🇭 Basel, Switzerland