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Evaluation of the Preventive Effect of Chlorhexidine Acetate Gargle for Upper Gastrointestinal Tract Infection After ESD

NCT03492827 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2018-04-10

No results posted yet for this study

Summary

Backgrounds： With the continuous improvement of sterilization and endoscopic structure, the infection caused by endoscopy has gradually declined.With the rapid development of digestive endoscopic therapy in the past decade, therapeutic endoscopy has been widely carried out worldwide. These techniques have caused the mucous membrane or deeper damage to achieve the goal of curing the disease. During therapeutic endoscopic procedures, endogenous bacteria may be ectopic to the blood circulation due to mucosal or deeper damage. The endoscope is used to in and out lumens multiple times, and the injections are injected into the tissues through the accessories. These processes may bring the pathogenic bacteria from the patient's mouth into the digestive tract through the endoscope and enter the blood through the damaged mucosa. In addition, bacteremia associated with endoscopic procedures may cause bacterial infections in distant organs (eg infective endocarditis).

Postoperative infection rates can reach 12-22% . The results of the etiological culture show that it is consistent with the bacteria of oral bacteria. It is possibly related to multiple passage into the digestive tract of endoscopic and accessory . However, the endoscopic operation process will inevitably lead to subsequent infections.

ESD treatment involves endoscopic multiple access to the upper digestive tract through the mouth, attachments and injection needles and other multiple exposure to the wound, so the probability of postoperative infection is significantly higher than the average endoscope.

Investigators proposed to gargle patients with chlorhexidine acetate before ESD to improve the oral microenvironment and reduce the pathogenic bacteria in the oral cavity, so as to observe whether it can achieve the effect of preventing postoperative infection.

Methods and patients

1. Objectives: This study is a prospective randomized controlled study in single center of Peking University Third Hospital. The purpose of the study is to evaluate the preventive effect of chlorhexidine acetate gargle on the infection of early upper gastrointestinal cancer after endoscopic ESD therapy.
2. Calculation of sample size: According to the postoperative infection rate of 10%, 25% improvement is given after the gargle is administered, and the error range is calculated at 2%. The sample size needs 306 cases.

Conditions

Interventions

DRUG

chlorhexidine acetate gargle

observe whether it can achieve the effect of preventing postoperative infection

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Yonghui Huang, MD · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492827 on ClinicalTrials.gov