Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index

April 10, 2021 updated by: Private Healthcare Institution Clinical Hospital RGD-Medicine

MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications.

The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler gastroenteroanastomosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

122

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 Locations

  • Russian Federation
      • Rostov-on-Don, Russian Federation, 344010
        • Recruiting
        • Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
        • Contact:
          • Arut Mezhunts
          • Phone Number: 89885637263

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • morbid obesity
  • BMI above 35 kg/m2 with obesity related comorbidity
  • BMI above 40 kg/m2
  • undergoing MGB/OAGB
  • no bile reflux during preoperative period

Exclusion Criteria:

  • revisional operations
  • therapy-resistant bile reflux during preoperative period
  • history of bariatric surgery

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: hand-sewn gastroenteroanastomosis
Diagnostic test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
ACTIVE_COMPARATOR: stapler gastroenteroanastomosis
Diagnostic test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success
Time Frame: 12 month
Determination of the BRI index in patients undergoing MGB/OAGB can be used as a screening method for diagnosing biliary reflux in order to prevent and develop tactic for further management of patients from a risk group of complications associated with the toxic effects of an aggressive bile
12 month

Collaborators and Investigators

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

Sponsor

Private Healthcare Institution Clinical Hospital RGD-Medicine

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)

December 29, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

March 8, 2022

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 10, 2021

First Posted (ACTUAL)

April 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 10, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCH-RR-2020-mo-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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