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NOT YET RECRUITING
NCT06836271
PHASE2

Cleaning the Biopsy Needle in TRUS Bx

Sponsor: Hitit University

View on ClinicalTrials.gov

Summary

Prostate cancer(PCa) is the second most common cancer diagnosed in men. Clinical suspicion of PCa is mentioned in patients with digital rectal examination findings and elevated serum PSA. Despite all the advances in radiological imaging methods, the gold standard method in the diagnosis of the disease is systematic prostate biopsy performed under the guidance of transrectal ultrasonography, which is an invasive procedure. In TRUS-guided transrectal prostate biopsy, bacteriuria may develop as a result of the rectum flora being injected into the urinary system through a biopsy needle. Infective complications may be encountered as a result of this contamination. Infective complications can present with conditions ranging from asymptomatic bacteriuria to sepsis. A study has shown that disinfection of the biopsy needle with isopropyl alcohol reduces sepsis due to prostate biopsy compared to the standard procedure. In another study, disinfection of the biopsy needle tip with formalin was found to be associated with a decrease in infectious complications after transrectal prostate biopsy. In this study, investigators aimed to conduct a prospective study comparing Transrectal Ultrasonography-guided Prostate Biopsy cases, in which the biopsy needle was cleaned with isopropyl alcohol, povidone iodine and formalin, and standard biopsy patients in terms of infectious complications.

Official title: The Effect of Cleaning the Biopsy Needle With Isopropyl Alcohol, Povidone Iodine and Formalin Before Transrectal Ultrasonography-guided Prostate Biopsy on Procedure-related Infective Complications

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-03-01

Completion Date

2025-06-30

Last Updated

2025-02-20

Healthy Volunteers

No

Interventions

DRUG

Isopropyl Alcohol

During repeated procedures while transrectal biopsy was being taken, the biopsy needle was disinfected with 70% Isopropyl alcohol every time it came into contact with the rectal mucosa.

DRUG

Povidine-iodine

During repeated procedures while transrectal biopsy was being taken, the biopsy needle was disinfected with povidine-iodine every time it came into contact with the rectal mucosa.

COMBINATION_PRODUCT

formaldehit

During repeated procedures while transrectal biopsy was being taken, the biopsy needle was disinfected with 10% formaldehit every time it came into contact with the rectal mucosa.

PROCEDURE

Standard BP control

No disinfection method is used in routine use in repetitive procedures when taking a transrectal biopsy.