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

NCT00373919 | Unknown

• 1 other identifier: erythro-esophagus
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Esophagectomy; Postoperative Complications

Interventions

intravenous (IV) administration of erythromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients after trans-hiatal esophagectomy

You may not qualify if:

• Allergy to erythromycin
• Use of phenothiazine
• QT prolongation
• Liver function test (LFT) abnormalities
• Myasthenia gravis
• Cardiomyopathy

Sponsors & Collaborators

• Kaplan Medical Center: lead

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Koram Klein, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoram Klein, MD

CONTACT

972-50-8213221; yoramkl@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Last Updated: March 5, 2007

Record last verified: 2006-08