Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

National Taiwan University

Status and phase: Unknown; Phase 2

Conditions: Anastomotic Leakage

Treatments: Other: Water; Drug: Mycostatin oral suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT00942526

200806035R

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

1

No Intervention group

Description:

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

2

Sham Comparator group

Description:

perioperative gargling with water

Treatment:

Other: Water

3

Experimental group

Description:

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

Treatment:

Drug: Mycostatin oral suspension