Different Limb Lengths in Gastric Bypass Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Morbid, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Long BPL LRYGB
* Procedure: Short BPL LRYGB


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long Biliopancreatic Limb LRYGB<br>LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm. | Procedure: Long BPL LRYGB<br>* LRYGB with an 180 cm BPL and an AL of 80 cm.<br>* Other names: LBPL LRYGB;|
| Active Comparator: Short Biliopancreatic Limb LRYGB<br>Standard LRYGB with a 80 cm BPL and a 180 cm long AL. | Procedure: Short BPL LRYGB<br>* The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.<br>* Other names: SBPL LRYGB;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roux-en-Y Gastric Bypass, Biliopancreatic Limb Length