RCT Comparing OAGB and Long Limb Roux Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.

Official Title
-----------------
A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: One-anastomosis gastric bypass
* Procedure: Long biliary limb Roux gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI over 35 and obesity related disease BMI over 40 age between 18-60 years agrees to participate in the study Exclusion Criteria: age under 18 years or over 60 years abundant adhesions discovered during the surgery active upper gastrointestinal ulcer disease prior bariatric surgery active symptomatic reflux disease active psychiatric disease (eg psychosis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Women<br> | Procedure: One-anastomosis gastric bypass<br>* One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)<br>Procedure: Long biliary limb Roux gastric bypass<br>* Other group is planned to receive a long biliary limb Roux gastric bypass<br>|
| Active Comparator: Men<br> | Procedure: One-anastomosis gastric bypass<br>* One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)<br>Procedure: Long biliary limb Roux gastric bypass<br>* Other group is planned to receive a long biliary limb Roux gastric bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss % | Calculated loss of the excess weight | 10 years | 
| Impact on type 2 diabetes mellitus | Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c % | 10 years | 
| Impact on type 2 diabetes mellitus | Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication) | 10 years | 
| Impact on hypertensive disease | Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended) | 10 years | 
| Impact on total cholesterol | Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L). | 10 years | 
| Impact on hyperlipidemia | Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L) | 10 years | 
| Impact on hyperlipidemia | Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L) | 10 years | 
| Impact on hyperlipidemia | Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L) | 10 years | 
| Impact on hyperlipidemias | Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional deficiencies: anemia | % of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L) | 10 years | 
| Nutritional deficiencies | Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L) | 10 years | 
| GERD | % of subjects reporting reflux disease symptoms and/or PPI usage after the surgery | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAGB, Long biliary limb Roux gastric bypass, Metabolic surgery, Obesity