Impact of Antibiotic Prophylaxis in Per-oral Endoscopic Myotomy for Esophageal Motor Disorders

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

COMPLETED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-06-30

Brief Summary

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No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety.

This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.

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Detailed Description

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Conditions

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Esophagus Disorder Esophageal Achalasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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POEM + Antibiotic prophylaxis

Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days

Antibiotics

Intervention Type DRUG

POEM + No antibiotic prophylaxis

No interventions assigned to this group

Interventions

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Antibiotics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision