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

Bile Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845438
• Other study ID #: CCH-RR-2020-mo-2
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: March 8, 2022

Study information

• Verified date: April 2021
• Source: Private Healthcare Institution Clinical Hospital RGD-Medicine
• Contact: Arut Mezhunts
• Phone: 89885637263
• Email: arut.mezhunts[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: March 8, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Reflux
• Gastroesophageal Reflux
• Stomach Ulcer
• Ulcer, Gastric

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"	Rostov-on-Don

Sponsors (1)

Lead Sponsor	Collaborator
Private Healthcare Institution Clinical Hospital RGD-Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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