Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

September 1, 2020 updated by: Daniel Moritz Felsenreich, Medical University of Vienna

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

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.

Study Overview

Detailed Description

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?

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gerhard Prager, Univ. Prof., Vienna Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 25, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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