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The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer

Phase 2
40 Years
85 Years
Open (Enrolling)
Anastomotic Leakage

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Trial Information

The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer


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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

all cause anastomotic leakage

Outcome Time Frame:

two years

Safety Issue:


Principal Investigator

Pei-Ming Huang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

June 2009

Completion Date:

December 2010

Related Keywords:

  • Anastomotic Leakage
  • esophageal cancer
  • anastomotic leakage
  • Prevention of anastomotic leakage after esophageal surgery
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Anastomotic Leak