Cleaning the Biopsy Needle in TRUS Bx

ConditionProstatic Cancer

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorHitit University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Oriented-coopere patients

Patients without active urinary tract infection - Patients without active urinary tract infection

Patients without bleeding diathesis

Patients who accept the study

Disqualifiers

Patients with active urinary tract infection

Patients with bleeding diathesis

Patients with sonal or cystofix

Patients with a history of previous prostate surgery

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.
Standard BP control
Procedure/Surgery
No disinfection method is used in routine use in repetitive procedures when taking a transrectal biopsy.

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: biopsy needle with formalinExperimental treatment 1 intervention

Group B: biopsy needle with povidone iodineExperimental treatment 1 intervention

Group C: Standart biyopsyActive comparator 1 intervention

Group D: biopsy needle with isopropyl alcoholExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hitit University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: