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Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia

NCT01750385 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-12-17

No results posted yet for this study

Summary

Peroral Endoscopic Myotomy (POEM) is a novel, promising endoscopic technique for achalasia because it is safer and more effective than traditional Heller's myotomy. However, the issue of antibiotic prophylaxis in POEM has evoked considerable controversy recently. Therefore, we conduct this study to elucidate the status of POEM-related bacteremia and procalcitonin levels in order to preliminary observe whether antibiotic prophylaxis is needed.

Conditions

  • Esophageal Achalasia

Interventions

DRUG

no antibiotic prophylaxis

These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.

DRUG

second-generation cephalosporin

These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Ping-Hong Zhou, M.D,PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01750385 on ClinicalTrials.gov