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Trial record 41 of 182 for:    ERYTHROMYCIN

The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00373919
Recruitment Status : Unknown
Verified August 2006 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 8, 2006
Last Update Posted : March 5, 2007
Sponsor:
Information provided by:
Kaplan Medical Center

Tracking Information
First Submitted Date  ICMJE September 7, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date March 5, 2007
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00373919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
Official Title  ICMJE Not Provided
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE
  • Esophagectomy
  • Postoperative Complications
Intervention  ICMJE Drug: intravenous (IV) administration of erythromycin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373919
Other Study ID Numbers  ICMJE erythro-esophagus
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Kaplan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Koram Klein, MD Kaplan Medical Center
PRS Account Kaplan Medical Center
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP