The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
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 Investigator Information
Lead Investigator: Kaplan Medical Center Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00373919
