Cleaning the Biopsy Needle in TRUS Bx

NCT06836271 | Not Yet Recruiting Phase 2

• 1 other identifier: HititUrology001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostatic Cancer

Keywords

Prostatic Neoplasms; Needle washing; Prostate biopsy; Sepsis

Outcome Measures

Primary Outcomes (1)

• Determination of sample size

  For the main (Primary) hypothesis in our study (The effect of cleaning the biopsy needle with isopropyl alcohol, formalin and povidone iodine before Transrectal Ultrasonography-guided Prostate Biopsy on procedure-related infective complications), power analysis was performed using f-test in independent groups. In order to reach 95% power with α=0.05 error (two-way hypothesis), it was determined that a minimum total of 176 patients were needed as a result of the power analysis calculated using Cohen's d=0.25 effect size calculated by using the literature information. In this study, we decided to enroll a total of 200 patients, with a minimum of 50 in each group. Patients will be evaluated with a post-operative survey. Patients will be followed for 4 weeks after the operation.

  6 months

Study Arms (4)

biopsy needle with formalin

EXPERIMENTAL

Combination Product: formaldehit

biopsy needle with povidone iodine

EXPERIMENTAL

Drug: Povidine-iodine

Standart biyopsy

ACTIVE COMPARATOR

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

Procedure: Standard BP control

biopsy needle with isopropyl alcohol

EXPERIMENTAL

Drug: Isopropyl Alcohol

Interventions

Isopropyl Alcohol DRUG

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.

biopsy needle with isopropyl alcohol

Povidine-iodine DRUG

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.

biopsy needle with povidone iodine

formaldehit COMBINATION_PRODUCT

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.

biopsy needle with formalin

Standard BP control PROCEDURE

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

Standart biyopsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Oriented-coopere patients
• Patients without active urinary tract infection - Patients without active urinary tract infection
• Patients without bleeding diathesis
• Patients who accept the study

You may not qualify if:

• Patients with active urinary tract infection
• Patients with bleeding diathesis
• Patients with sonal or cystofix
• Patients with a history of previous prostate surgery

Sponsors & Collaborators

• Hitit University: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Sepsis

Interventions

2-Propanol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals

Central Study Contacts

Mustafa S CAGLAYAN

CONTACT

905074311951; serdar.09.09@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 4
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02