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Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

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ClinicalTrials.gov Identifier: NCT00942526
Recruitment Status : Unknown
Verified July 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 21, 2009
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Anastomotic Leakage Drug: Mycostatin oral suspension Other: Water Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : June 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Nystatin

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
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
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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
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Contact: Pei-Ming Huang, MD +886-2-23123456 ext 63509 e370089@gmail.com

Locations
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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
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Principal Investigator: Pei-Ming Huang, MD Department of Surgery, National Taiwan University Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Pei-Ming Huang, Department of Surgery, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00942526    
Other Study ID Numbers: 200806035R
First Posted: July 21, 2009    Key Record Dates
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:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes
Nystatin
Anti-Bacterial Agents
 Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action