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Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

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 July 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942526
First Posted: July 21, 2009
Last Update Posted: July 21, 2009
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:
National Taiwan University Hospital
  Purpose
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.

Condition Intervention Phase
Anastomotic Leakage Drug: Mycostatin oral suspension Other: Water Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • all cause anastomotic leakage [ Time Frame: two years ]

Secondary Outcome Measures:
  • Time variation of starting oral feeding and hospital stay [ Time Frame: two years ]

Estimated Enrollment: 120
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
no intervention with perioperative oral anti-infective agent or water for gargling
Sham Comparator: 2
perioperative gargling with water
Other: Water
perioperative gargling with water
Experimental: 3
perioperative oral gargling with oral anti-infective agent for seven days
Drug: Mycostatin oral suspension
peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days

Detailed Description:

Goal:

The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. We will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing.

Method:

  1. Design:

    One hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. Minimization stratified randomization will be applied. Oral anti-infective gargling agent, Mycostatin oral suspension, will be employed for one week before operation. The first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent.

    An end-to-side two-layer esophagogastric anastomosis will be constructed using interrupted sutures with metallic staple through cervical wound. On the other hand, the anastomotic leakage rates in different groups will be investigated.

  2. Data Collection and Statistic Analysis:

The records of all patients, various biologic parameters, and the management of leakage are analyzed. Thirty-day morbidity and mortality are determined, and stepwise multivariable logistic regression analysis assesses the effect of preoperative and postoperative variables on anastomotic leakage. Time variation of starting oral feeding and hospital stay are compared using the Kaplan-Meier method.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • carcinoma of the esophagus, operable stage I to III

Exclusion Criteria:

  • patients who were inoperable,
  • patients who had obvious impaired blood supply of gastric substitutes, and
  • patients who had non-cervical esophagogastrostomy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942526


Contacts
Contact: Pei-Ming Huang, MD +886-2-23123456 ext 63509 e370089@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Pei-Ming Huang, MD    +886-2-23123456 ext 63509    e370089@gmail.com   
Principal Investigator: Pei-Ming Huang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Pei-Ming Huang, MD Department of Surgery, National Taiwan University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Pei-Ming Huang, Department of Surgery, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00942526     History of Changes
Other Study ID Numbers: 200806035R
First Submitted: July 20, 2009
First Posted: July 21, 2009
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by National Taiwan University Hospital:
esophageal cancer
anastomotic leakage
Prevention of anastomotic leakage after esophageal surgery

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes
Anti-Infective Agents
Nystatin
Anti-Bacterial Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action