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

S

Société Française d'Endoscopie Digestive

Status

Completed

Conditions

Esophagus Disorder
Esophageal Achalasia

Treatments

Drug: Antibiotics

Study type

Observational

Funder types

Other

Identifiers

NCT03944863
Antibiotic Prophylaxis POEM

Details and patient eligibility

About

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.

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

  • Under-age patients were excluded

Trial design

252 participants in 2 patient groups

POEM + Antibiotic prophylaxis
Description:
Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days
Treatment:
Drug: Antibiotics
POEM + No antibiotic prophylaxis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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