NCT03944863

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

Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 252 (actual)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophagus Disorder
• Esophageal Achalasia

Interventions

Type	Name	Description
DRUG	Antibiotics

Timeline

• Start date: 2013-12-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2019-05-10
• Last updated: 2019-05-10

Regulatory

• FDA-regulated drug study