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NCT04219787Active, not recruiting

Different Limb Lengths in Gastric Bypass Surgery

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

Source: ClinicalTrials.gov · Last updated 13 Nov 2023

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
800 (estimated)
First submitted
3 Jan 2020
Start date
1 Jun 2020
Primary completion date
30 Nov 2028
Lead sponsor
Clarunis - Universitäres Bauchzentrum Basel
NCT number
NCT04219787

What you commit to

  • Study type: Interventional
  • Planned participants: 800
  • From 1 Jun 2020 to the primary completion date, 30 Nov 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • general contraindications to kind of surgery
  • known or suspected non-compliance, drug or alcohol abuse

Other illness

  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
  • inflammatory bowel disease

Age

  • age \< 18 years or \> 65 years

Other

  • participation in another study
  • BMI \> 60 kg/m2
  • height \< 145 cm
  • CL length of \< 180 cm as measured intraoperatively
  • ASA physical status classification \> III

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clarunis University Center for Gastrointestinal and Liver Diseases
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.