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

Completed

• Conditions: Esophageal Achalasia; Esophagus Disorder
• Interventions: Drug: Antibiotics

• Registration Number: NCT03944863
• Lead Sponsor: Société Française d'Endoscopie Digestive

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Last Update Submitted: 2019-05-07
• Study First Posted: 2019-05-10
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POEM + Antibiotic prophylaxis	Antibiotics	Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days

Primary Outcome Measures

Name	Time	Method
The occurence of postoperative complications, according to Cotton's classification	7 Days	Depending on whether or not antibiotic prophylaxis was administered

Secondary Outcome Measures

Name	Time	Method
The evaluation of the efficacy of the procedure	1 Month	According to the Eckard score
The occurence of perioperative and postoperative complications	7 Days	According to Cotton's classification
The C-Reactive Protein and white blood cells count sampled	1 Day	Blood test the day after the procedure, level of CRP in mg/L