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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04845438
Enrollment
122
Registered
2021-04-15
Start date
2020-12-29
Completion date
2022-03-08
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Reflux, Ulcer, Gastric

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.

Interventions

DIAGNOSTIC_TESTfibrogastroscopy, 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

Sponsors

Private Healthcare Institution Clinical Hospital RGD-Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success12 monthDetermination 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

Countries

Russia

Contacts

Primary ContactArut Mezhunts
arut.mezhunts@mail.ru89885637263

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026