The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
Sponsor
Kaplan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00373919
Collaborator
(none)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kaplan Medical Center
Investigators
- Principal Investigator: Koram Klein, MD, Kaplan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00373919
Other Study ID Numbers:
- erythro-esophagus
First Posted:
Sep 8, 2006
Last Update Posted:
Mar 5, 2007
Last Verified:
Aug 1, 2006
Additional relevant MeSH terms: