Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00942526
First received: July 20, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 20, 2009
July 20, 2009
June 2009
December 2010   (final data collection date for primary outcome measure)
all cause anastomotic leakage [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Time variation of starting oral feeding and hospital stay [ Time Frame: two years ] [ Designated as safety issue: No ]
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.
 
Recruiting
120
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.
Both
40 Years to 85 Years
No
Contact: Pei-Ming Huang, MD +886-2-23123456 ext 63509 e370089@gmail.com
Taiwan
 
NCT00942526
200806035R
Yes
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