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

Not Applicable

• Conditions: Bile Reflux; Ulcer, Gastric
• Interventions: Diagnostic Test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

• Registration Number: NCT04845438
• Lead Sponsor: Private Healthcare Institution Clinical Hospital RGD-Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-29
• Status Verified: 2021-04
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Last Update Submitted: 2021-04-10
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-15
• Primary Completion: 2021-11-01
• Study Completion: 2022-03-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hand-sewn gastroenteroanastomosis	fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index	-
stapler gastroenteroanastomosis	fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index	-

Primary Outcome Measures

Name	Time	Method
Success	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

Trial Locations

Locations (1)

Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"; 🇷🇺 Rostov-on-Don, Russian Federation