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

Private Healthcare Institution Clinical Hospital RGD-Medicine

Status: Unknown

Conditions: Bile Reflux; Ulcer, Gastric

Treatments: Diagnostic Test: fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index

Study type: Interventional

Funder types: Other

Identifiers

NCT04845438

CCH-RR-2020-mo-2

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups

hand-sewn gastroenteroanastomosis

Active Comparator group

Treatment:

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

stapler gastroenteroanastomosis

Active Comparator group

Treatment:

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