Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373919
Status:
UNKNOWN
Last Update Posted:
2007-03-05
First Post:
2006-09-07
Brief Title:
The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
Sponsor:
Kaplan Medical Center
Organization:
Kaplan Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None