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

NCT03944863 | Completed FDA Drug

• 1 other identifier: Antibiotic Prophylaxis POEM
• Study Type: observational
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophagus Disorder; Esophageal Achalasia

Keywords

antibiotic prophylaxis; per oral endoscopic myotomy

Outcome Measures

Primary Outcomes (1)

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

  Depending on whether or not antibiotic prophylaxis was administered

  7 Days

Secondary Outcomes (3)

• The evaluation of the efficacy of the procedure

  1 Month

• The occurence of perioperative and postoperative complications

  7 Days

• The C-Reactive Protein and white blood cells count sampled

  1 Day

Study Arms (2)

POEM + Antibiotic prophylaxis

Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days

Drug: Antibiotics

POEM + No antibiotic prophylaxis

Interventions

Antibiotics DRUG

POEM + Antibiotic prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Under-age patients were excluded

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

MeSH Terms

Conditions

Esophageal Diseases; Esophageal Achalasia

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor,Physician Doctor, Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 10, 2019
• Study Start: December 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05