Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03944863
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
VANBIERVLIET, 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.


Condition or disease Intervention/treatment
Esophagus Disorder Esophageal Achalasia Drug: Antibiotics

Layout table for study information
Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders
Study Start Date : December 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
POEM + Antibiotic prophylaxis
Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days
Drug: Antibiotics
POEM + No antibiotic prophylaxis



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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. Under-age patients were excluded.
Criteria

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

Layout table for additonal information
Responsible Party: VANBIERVLIET, Medical Doctor,Physician Doctor, Principal Investigator, Société Française d'Endoscopie Digestive
ClinicalTrials.gov Identifier: NCT03944863     History of Changes
Other Study ID Numbers: Antibiotic Prophylaxis POEM
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VANBIERVLIET, Société Française d'Endoscopie Digestive:
antibiotic prophylaxis
per oral endoscopic myotomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Disease
Esophageal Achalasia
Motor Disorders
Esophageal Diseases
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Pathologic Processes
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases
Mental Disorders
Anti-Infective Agents
Antitubercular Agents