Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anastomotic Leakage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

2

perioperative gargling with water

Group Type SHAM_COMPARATOR

Water

Intervention Type OTHER

perioperative gargling with water

3

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

Group Type EXPERIMENTAL

Mycostatin oral suspension

Intervention Type DRUG

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

Interventions

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Mycostatin oral suspension

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

Intervention Type DRUG

Water

perioperative gargling with water

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No