Different Limb Lengths in Gastric Bypass Surgery

Hypertension Clinical Trial

— SLIM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04219787
• Other study ID #: 2019-02392
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 30, 2028

Study information

• Verified date: November 2023
• Source: Clarunis - Universitäres Bauchzentrum Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemias
• Hypertension
• Obesity, Morbid
• Sleep Apnea

Intervention

Procedure:
• Long BPL LRYGB
LRYGB with an 180 cm BPL and an AL of 80 cm.
• Short BPL LRYGB
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Locations

Country	Name	City	State
Switzerland	Clarunis University Center for Gastrointestinal and Liver Diseases	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Clarunis - Universitäres Bauchzentrum Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint	Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).	From baseline to 5 years after surgery.
Secondary	Secondary endpoints	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.	From baseline to 5 years after surgery.