Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures
Bile Reflux
About this trial
This is an interventional diagnostic trial for Bile Reflux focused on measuring Omega Loop Gastric Bypass, Reflux, Mini Gastric Bypass
Eligibility Criteria
Inclusion Criteria:
- Age between 20 and 70 years
- Body Mass Index ≥ 35.0 kg/m2
- Exclusion of psychological, endocrinological and anesthesiological contraindications
- Willingness to be assigned to either of the two groups
- Follow-up anticipation
- Willingness to attend all follow-up visits
- Written informed consent
Exclusion Criteria:
- recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult),
- pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years),
- significant anemia or coagulopathy,
- serum creatinin ≥ 1.5 mg/dl.,
- serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months,
- intraabdominal sepsis (except uncomplicated appendicitis or diverticulitis over 6 months prior to the study),
- organ transplantations,
- anamnestic HIV infection, active TBC, active malaria, chronic Hepatitis B or C, liver cirrhosis,
- alcohol or drug addiction (except caffeine, nicotine) in history,
- acute psychiatric disease interfering with the proposed trial,
- other chronic disease which might interfere with the participation.
Also, patients who are pregnant or plan a pregnancy within the following two years as well as patients who have been included in another study, will be excluded.
Note: Exclusion can be performed by a study coordinator at any time.
Hiatal hernia is not considered an exclusion criterion in this study.
Sites / Locations
- Medical University ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Anti-reflux sutures
No anti-reflux sutures
Omega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™.
Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™.