Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension, Obesity, Morbid, Sleep Apnea
Conditions
Keywords
Roux-en-Y Gastric Bypass, Biliopancreatic Limb Length
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.
Interventions
PROCEDURELong BPL LRYGB
LRYGB with an 180 cm BPL and an AL of 80 cm.
PROCEDUREShort BPL LRYGB
The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Sponsors
Clarunis - Universitäres Bauchzentrum Basel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed