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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373919
First Posted: September 8, 2006
Last Update Posted: March 5, 2007
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.
Information provided by:
Kaplan Medical Center
September 7, 2006
September 8, 2006
March 5, 2007
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Complete list of historical versions of study NCT00373919 on ClinicalTrials.gov Archive Site
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The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy
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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
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
  • Esophagectomy
  • Postoperative Complications
Drug: intravenous (IV) administration of erythromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00373919
erythro-esophagus
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Kaplan Medical Center
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Principal Investigator: Koram Klein, MD Kaplan Medical Center
Kaplan Medical Center
August 2006

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