Clinical trial NCT04219787: Different Limb Lengths in Gastric Bypass Surgery
Official title: Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Diabetes Mellitus, Type 2
Hypertension
Dyslipidemias
Sleep Apnea
Keywords: Roux-en-Y Gastric Bypass
Biliopancreatic Limb Length
Lead sponsor: Clarunis - Universitäres Bauchzentrum Basel
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Primary endpoint
timeFrame: From baseline to 5 years after surgery.
Secondary outcomes:
measure: Secondary endpoints
timeFrame: From baseline to 5 years after surgery.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clarunis University Center for Gastrointestinal and Liver Diseases
Study officials:
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Marko Kraljevic, MD
role: STUDY_CHAIR
affiliation: University Hospital Zurch
name: Marco Bueter, MD, Professor
role: STUDY_CHAIR
References:
citation: Kraljevic M, Schneider R, Wolnerhanssen B, Bueter M, Delko T, Peterli R. Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM). Trials. 2021 May 19;22(1):352. doi: 10.1186/s13063-021-05313-6.