We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

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: 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
Information provided by:

July 20, 2009
July 21, 2009
July 21, 2009
June 2009
December 2010   (Final data collection date for primary outcome measure)
all cause anastomotic leakage [ Time Frame: two years ]
Same as current
No Changes Posted
Time variation of starting oral feeding and hospital stay [ Time Frame: two years ]
Same as current
Not Provided
Not Provided
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer
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.


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.


  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.

Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anastomotic Leakage
  • Drug: Mycostatin oral suspension
    peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days
  • Other: Water
    perioperative gargling with water
  • No Intervention: 1
    no intervention with perioperative oral anti-infective agent or water for gargling
  • Sham Comparator: 2
    perioperative gargling with water
    Intervention: Other: Water
  • Experimental: 3
    perioperative oral gargling with oral anti-infective agent for seven days
    Intervention: Drug: Mycostatin oral suspension

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Pei-Ming Huang, Department of Surgery, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Pei-Ming Huang, MD Department of Surgery, National Taiwan University Hospital
National Taiwan University Hospital
July 2009

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