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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03944863
Enrollment
252
Registered
2019-05-10
Start date
2013-12-31
Completion date
2018-06-30
Last updated
2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Achalasia, Esophagus Disorder

Keywords

antibiotic prophylaxis, per oral endoscopic myotomy

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.

Interventions

DRUGAntibiotics

Sponsors

Société Française d'Endoscopie Digestive
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The occurence of postoperative complications, according to Cotton's classification7 DaysDepending on whether or not antibiotic prophylaxis was administered

Secondary

MeasureTime frameDescription
The evaluation of the efficacy of the procedure1 MonthAccording to the Eckard score
The occurence of perioperative and postoperative complications7 DaysAccording to Cotton's classification
The C-Reactive Protein and white blood cells count sampled1 DayBlood test the day after the procedure, level of CRP in mg/L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026