Cleaning the Biopsy Needle in TRUS Bx

February 14, 2025 updated by: Mustafa Serdar CAGLAYAN, Hitit University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective To reduce procedure-related infective complications after Transrectal Ultrasonography-guided Prostate Biopsy Method Prostate cancer is the second most common cancer diagnosed in men. In 2020, approximately 1.4 million people were diagnosed worldwide [1,2]. The number of PCa detected by autopsy is roughly the same worldwide [3]. In a systematic review of autopsy studies, the prevalence of PCa under the age of 30 years was reported to be 5% (confidence interval-CI: 95%), with a 1.7 (1.6-1.8) (odds ratio-OR) fold increase per 10 years, reaching 59% (48-71%) over the age of 79 years [4].

Clinical suspicion of PCa is mentioned in patients with finger rectal examination findings and elevated serum PSA. Despite all the advances in radiologic imaging modalities, the gold standard method for the diagnosis of the disease is systematic prostate biopsy under transrectal ultrasonography guidance, which is an invasive procedure. [5]

Transrectal ultrasonography (TRUS) was first described by Wild and Reid in 1957. TRUS plays an important role in prostate diseases as it is inexpensive, easily applicable and guides biopsy. Conventional TRUS-guided prostate biopsy is performed with 12 pieces of tru-cut samples taken systematically and randomized.

Although it can be safely performed in the outpatient setting and is easily tolerated by patients, Transrectal Ultrasonography-guided Prostate Biopsy can lead to serious complications such as hematuria, rectal bleeding, acute urinary retention, urinary tract infection and sepsis.

Urinary tract infection accompanied by fever is the most common complication after biopsy. Bacteriuria after prostate biopsy is reported between 20% and 50% in the literature. [6] Several studies have shown that antibiotic prophylaxis largely prevents infection. [6,7]

During TRUS-guided transrectal prostate biopsy, bacteriuria may develop as a result of the rectal flora being introduced into the urinary system through the biopsy needle. Infective complications may occur as a result of this transmission. Infective complications can range from asymptomatic bacteriuria to sepsis.

In one study, disinfection of the biopsy needle with isopropyl alcohol was shown to reduce prostate biopsy-related sepsis compared to the standard procedure. [8] In another study, disinfection of the biopsy needle tip with formalin was associated with a decrease in infectious complications after transrectal prostate biopsy.[9] In this study, investigators aimed to prospectively examine the infectious complications occurring in a total of 200 cases of Transrectal Ultrasonography-guided Prostate Biopsy to be performed in our clinic in 2025.

In 200 patients who underwent Trans Rectal Ultrasonography-guided prostate biopsy procedure, infective parameters, signs and symptoms such as fever, dysuria, and possible complications such as hospitalization requirement, sepsis will be prospectively investigated to evaluate postop infective complications of disinfection of the biopsy needle with formalin, povidone iodine or isopropyl alcohol before each biopsy.

In the study, each patient will undergo bt-enema for bowel cleansing before the procedure, rectal cleansing with povidone iodine, and prophylactic antibiotherapy will be started 3 days before the procedure. Patients will be randomly divided into four groups, 50 patients will be disinfected with Bx needle formalin before the procedure, 50 patients will be disinfected with Bx needle povidone iodine before the procedure, 50 patients will be disinfected with Bx needle isopropyl alcohol before the procedure, and the other 50 patients will not be disinfected with isopropyl alcohol, povidone iodine or formalin as in the standard practice. In the first 1 week after the procedure, their symptoms will be questioned by daily phone calls. Within 1 week, complete urinalysis and urine culture will be obtained from symptomatic patients (burning during urination, fever, chills, chills). Patients with a fever above 37.8 will be hospitalized after a complete urine test, urine and blood culture. On day 14, outpatients will be called for outpatient follow-up and patients without any symptoms will be lost to follow-up.

Estimated completion time of the study 6 months Inclusion criteria

  • Oriented-coopere patients
  • Patients without active urinary tract infection - Patients without active urinary tract infection
  • Patients without bleeding diathesis
  • Patients who accept the study Exclusion criteria
  • Patients with active urinary tract infection
  • Patients with bleeding diathesis
  • Patients with sonal or cystofix
  • Patients with a history of previous prostate surgery 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, investigators decided to enroll a total of 200 patients, with a minimum of 50 in each group.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with active urinary tract infection

    • Patients with bleeding diathesis
    • Patients with sonal or cystofix
    • Patients with a history of previous prostate surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: biopsy needle with formalin
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.
Experimental: biopsy needle with povidone iodine
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.
Active Comparator: Standart biyopsy
No disinfection method is used in routine use in repetitive procedures when taking a transrectal biopsy.
Procedure: Standard BP control
No disinfection method is used in routine use in repetitive procedures when taking a transrectal biopsy.
Experimental: biopsy needle with isopropyl alcohol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of sample size
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HititUrology001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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