Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

Phase 2

• Conditions: Anastomotic Leakage
• Interventions: Other: Water; Drug: Mycostatin oral suspension

• Registration Number: NCT00942526
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-20
• Last Update Submitted: 2009-07-20
• Study First Posted: 2009-07-21
• Last Update Posted: 2009-07-21
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• carcinoma of the esophagus, operable stage I to III

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Exclusion Criteria

• patients who were inoperable,
• patients who had obvious impaired blood supply of gastric substitutes, and
• patients who had non-cervical esophagogastrostomy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Water	perioperative gargling with water
3	Mycostatin oral suspension	perioperative oral gargling with oral anti-infective agent for seven days

Primary Outcome Measures

Name	Time	Method
all cause anastomotic leakage	two years

Secondary Outcome Measures

Name	Time	Method
Time variation of starting oral feeding and hospital stay	two years

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan