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

Esophageal Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944863
• Other study ID #: Antibiotic Prophylaxis POEM
• Status: Completed
• Start date: December 2013
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2019
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Esophageal Achalasia
• Esophageal Diseases
• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse
• Esophagus Disorder
• Motor Disorders

Intervention

Drug:
• Antibiotics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurence of postoperative complications, according to Cotton's classification	Depending on whether or not antibiotic prophylaxis was administered	7 Days
Secondary	The evaluation of the efficacy of the procedure	According to the Eckard score	1 Month
Secondary	The occurence of perioperative and postoperative complications	According to Cotton's classification	7 Days
Secondary	The C-Reactive Protein and white blood cells count sampled	Blood test the day after the procedure, level of CRP in mg/L	1 Day