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OpenTrials
Completed

NCT Number: NCT03944863

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

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.

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Key information

Conditions

Esophagus Disorder Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotics

Drug

Primary outcomes

  1. The occurence of postoperative complications, according to Cotton's classification

    Time frame: 7 Days

    Depending on whether or not antibiotic prophylaxis was administered

Secondary outcomes

  1. The evaluation of the efficacy of the procedure

    Time frame: 1 Month

    According to the Eckard score

  2. The occurence of perioperative and postoperative complications

    Time frame: 7 Days

    According to Cotton's classification

  3. The C-Reactive Protein and white blood cells count sampled

    Time frame: 1 Day

    Blood test the day after the procedure, level of CRP in mg/L

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 10, 2019
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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