Skip to content

Comparing the quality of soft endoscope reprocessing processes in China and Europe on endoscope disinfection:A single-center randomized controlled study

A comparative study on the disinfection quality of soft endoscopes by improving the endoscopic disinfection process

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095794
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive disorders

Interventions

Experimental group:Adopting the European soft endoscope reprocessing process to handle the used soft endoscope
Control group:Using WS507-2016 "Technical Specification for Cleaning and Disinfection of Soft Endoscopes" to handle soft endoscopes after use

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 36 gastroscopes and colonoscopes were included in two consecutive biological cultures

Exclusion criteria

Exclusion criteria: 1. The endoscope was found to be damaged during leak detection, cleaning, and disinfection processes; 2. Malfunction or abnormal operating parameters of the fully automatic endoscope cleaning machine during the endoscopic cleaning process; 3. During the endoscopic decontamination process, it was discovered that the decontamination personnel violated the decontamination procedures

Design outcomes

Primary

MeasureTime frame
Microbial colony count in soft endoscopic biological culture;

Secondary

MeasureTime frame
Determination value of protein residue in soft endoscope;ATP measurement value of flexible endoscope;

Countries

China

Contacts

Public ContactLiang Huang

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

361765832@qq.com+86 136 6661 8249

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026