Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
Primary Purpose
Ulcer, Gastric, Bile Reflux
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
Sponsored by
About this trial
This is an interventional diagnostic trial for Ulcer, Gastric
Eligibility Criteria
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
Sites / Locations
- Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
hand-sewn gastroenteroanastomosis
stapler gastroenteroanastomosis
Arm Description
Outcomes
Primary Outcome Measures
Success
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04845438
First Posted
April 10, 2021
Last Updated
April 10, 2021
Sponsor
Private Healthcare Institution Clinical Hospital RGD-Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04845438
Brief Title
Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
Official Title
Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
March 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Private Healthcare Institution Clinical Hospital RGD-Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer, Gastric, Bile Reflux
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hand-sewn gastroenteroanastomosis
Arm Type
Active Comparator
Arm Title
stapler gastroenteroanastomosis
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
Intervention Description
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
Primary Outcome Measure Information:
Title
Success
Description
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
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arut Mezhunts
Phone
89885637263
Email
arut.mezhunts@mail.ru
Facility Information:
Facility Name
Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
City
Rostov-on-Don
ZIP/Postal Code
344010
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arut Mezhunts
Phone
89885637263
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
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