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

NCT ID: NCT04845438

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-29

Study Completion Date

2022-03-08

Brief Summary

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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

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Conditions

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Ulcer, Gastric Bile Reflux

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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hand-sewn gastroenteroanastomosis

Group Type ACTIVE_COMPARATOR

fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

Intervention Type DIAGNOSTIC_TEST

fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

stapler gastroenteroanastomosis

Group Type ACTIVE_COMPARATOR

fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

Intervention Type DIAGNOSTIC_TEST

fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Private Healthcare Institution Clinical Hospital RGD-Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"

Rostov-on-Don, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Arut Mezhunts

Role: CONTACT

89885637263

Facility Contacts

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Arut Mezhunts

Role: primary

89885637263

Other Identifiers

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CCH-RR-2020-mo-2

Identifier Type: -

Identifier Source: org_study_id

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