Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

Study Overview
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Brief Summary
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This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients. Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.

Detailed Description
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Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases). The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anastomosis (instead of two) and therefore potentially reducing morbidity and mortality whilst maintaining comparable excess weight loss. However, since this new type of gastric bypass is similar to the former Billroth II resection (BII), the carcinoma risk is a concern. The OLGB is different from the BII resection in many ways. For instance, it involves creating an approximately 10 cm long narrow gastric pouch which could prevent the suspected underlying pathogenetic mechanism: biliary reflux to the gastric tube and subsequently to the esophagus. Biliary reflux is suspected to stimulate squamous esophageal cells and Barrett's epithelial cells to produce inflammatory mediators and therefore cause oxidative stress, DNA damage and apoptosis which might lead to adenocarcinoma. Worldwide, there are currently two different ways to perform an OLGB: with or without anti-reflux sutures, which involve sewing the biliopancreatic limb to the staple line of the pouch using V-Loc (non-absorbable) moving upwards as far as easily possible without creating any tension. This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus?

Official Title
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Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study

Conditions
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Bile Reflux

Intervention / Treatment
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* Procedure: Omega Loop Gastric Bypass
* Device: Bilitec 2000™
* Device: V-Loc


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anti-reflux sutures<br>Omega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™. | Procedure: Omega Loop Gastric Bypass<br>* Bariatric/metabolic surgical procedure<br>* Other names: Single Anastomosis Gastric Bypass;Device: Bilitec 2000™<br>* The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.<br>Device: V-Loc<br>* Sewing device to perform the anti-reflux sutures.<br>|
| Active Comparator: No anti-reflux sutures<br>Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™. | Procedure: Omega Loop Gastric Bypass<br>* Bariatric/metabolic surgical procedure<br>* Other names: Single Anastomosis Gastric Bypass;Device: Bilitec 2000™<br>* The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile Reflux | The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Biliary exposure will therefore be assessed before and 12 months after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. | 1 year | 
| Bile Reflux | The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Extensive biopsies of the gastric pouch and gastroesophageal junction will be taken to prove histological changes due to biliary reflux. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Assessing inflammation before and 12 months after surgery using gastroscopy with biopsy. | 1 year | 
| Weight loss | Measuring excess weight loss (EWL), to reveal any changes in patients' weight | 1 year | 
| BMI loss | Excess BMI loss (EBMIL), to reveal any changes in patients' BMI | 1 year | 
| Complications by point in time/stage | Early postoperative complications (occurring within 30 days) Late postoperative complications (occurring after 30 days) | 1 year | 
| Complications by severity | Moderate complications (not requiring additional surgical intervention) Severe complications (requiring surgical intervention) | 1 year | 
| Resolution of hyperlipidemia | Collecting evidence for the resolution of hyperlipidemia | 1 year | 
| Resolution of hypertension | Collecting evidence for the resolution of hypertension | 1 year | 
| Resolution of diabetes | Collecting evidence for the resolution of diabetes | 1 year | 
| Resolution of sleep apnea | Collecting evidence for the resolution of sleep apnea | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega Loop Gastric Bypass, Reflux, Mini Gastric Bypass