Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2020
CompletedFirst Submitted
Initial submission to the registry
April 10, 2021
CompletedFirst Posted
Study publicly available on registry
April 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2022
CompletedApril 15, 2021
April 1, 2021
10 months
April 10, 2021
April 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 month
Study Arms (2)
hand-sewn gastroenteroanastomosis
ACTIVE COMPARATORstapler gastroenteroanastomosis
ACTIVE COMPARATORInterventions
fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- revisional operations
- therapy-resistant bile reflux during preoperative period
- history of bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
Rostov-on-Don, 344010, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2021
First Posted
April 15, 2021
Study Start
December 29, 2020
Primary Completion
November 1, 2021
Study Completion
March 8, 2022
Last Updated
April 15, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share