Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy. Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence. Design: This is a prospective, randomized, double blind, placebo controlled study. Number of patients: 30. Inclusion Criteria: - Patients after trans-hiatal esophagectomy...
Date First Received: September 7, 2006
Last Updated: March 2, 2007
Verified by: Kaplan Medical Center, August 2006
Clinical Trial Phase: N/A | Start Date:
Overall Status: Not yet recruiting
Brief Summary
Condition Keyword(s):
Intervention(s):
Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy.
Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromycin will reduce leak occurrence.
Design: This is a prospective, randomized, double blind, placebo controlled study.
Number of patients: 30.
Inclusion Criteria: - Patients after trans-hiatal esophagectomy
Exclusion Criteria: - Allergy to erythromycin - Use of phenothiazine - QT prolongation - Liver function test (LFT) abnormalities - Myasthenia gravis - Cardiomyopathy
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: intravenous (IV) administration of erythromycin
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients after trans-hiatal esophagectomy
Exclusion Criteria:
- Allergy to erythromycin
- Use of phenothiazine
- QT prolongation
- Liver function test (LFT) abnormalities
- Myasthenia gravis
- Cardiomyopathy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Kaplan Medical Center
Overall Clinical Trial Officials and Contacts
Koram Klein, MD Principal Investigator Kaplan Medical Center
Overall Contact: Yoram Klein, MD 972-50-8213221 yoramkl@clalit.org.il
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00373919
Study ID Number: erythro-esophagus
ClinicalTrials.gov Identifier: NCT00373919
Health Authority: Israel: Ministry of Health
Clinical Trials Authorship and Review
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