Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Anastomotic Leak

Postoperative Complications

Esophageal Cancer

Anti-Infective Agents

All Drugs and Chemicals

Nystatin

Anti-Bacterial Agents

Clotrimazole

Miconazole

Antifungal Agents

Ionophores

no intervention with perioperative oral anti-infective agent or water for gargling

perioperative oral gargling with oral anti-infective agent for seven days

peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days

Mycostatin oral suspension

Water

Pei-Ming Huang, MD

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.

Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

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

National Taiwan University Hospital

Pei-Ming Huang

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage	NCT00942526	Anastomotic Lea...	Mycostatin oral... Water	40 Years - 85 Years	National Taiwan University Hospital
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage	NCT00942526	Anastomotic Lea...	Mycostatin oral... Water	40 Years - 85 Years	National Taiwan University Hospital

Spots Global Cancer Trial Database for mycostatin oral suspension