Trial Information

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

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.