Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy

NCT ID: NCT03879486

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-07-24

Brief Summary

The main purpose of this study is to compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy. The secondary objective is to evaluate predictive factors of infectious complications after prostate biopsy. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different groups: group A - rectal cleansing and disinfection of the needle tip vs group B - controls.

Detailed Description

Prostate cancer is the most common neoplasm of solid organs in Brazil. Definitive diagnosis of the tumor is established through prostate biopsy, indicated in patients with elevated levels of PSA or suspicious rectal examination. The ultrasound or MRI-guided prostate biopsy is mostly performed through the transrectal route worldwide. Although it is a relatively safe procedure, transrectal prostate biopsy (TRUSB) can present several complications, such bleeding, acute urinary retention or infection. Infectious complications are an important concern for the urologist and have different presentation, ranging from isolated fever to severe sepsis. Antibiotic prophylaxis is an effective widely used practice, however, due to increasing rates of bacterial resistance, there is a growing trend in the incidence of infectious complications after TRUSB. Therefore, alternative strategies to decrease infections rates following biopsies are welcome. Our aim was to compare the infectious complications of intrarectal povidone-iodine cleansing associated to formalin disinfection of biopsy needle tip at prostate biopsy.

A prospective controlled study will be conducted enrolling 1152 consecutive prostate biopsies in a single center high volume urology Brazilian Public Hospital. The patients will be randomized at a 1: 1 ratio for two different groups: group A - rectal cleansing and disinfection of the needle tip vs. Group B - controls at transrectal ultrasound guided prostate biopsy. Patients will obtain a urine culture 48 hours after biopsy and complete a telephone interview 7 days after undergoing the procedure. The primary endpoint will be the rate of infectious complications, defined as 1 or more of the following events: fever ≥37.8 ºC; urinary tract infection (UTI) or sepsis (standardized definition). We will also evaluate the predictive factors of infectious complications

Conditions

Prostate Cancer; Prostatic Neoplasms; Prostate Biopsy; Prostatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PVPI intervention

rectal cleansing and disinfection of the needle tip at transrectal ultrasound guided prostate biopsy

Group Type: EXPERIMENTAL

Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy

Intervention Type: OTHER

The examiner will use a gauze soaked and saturated with iodopovidone and perform a mechanical friction motion on the anterior wall of the rectum, at least 5 times from one margin to another of the prostate laterally-laterally. A period of two (2) minutes shall be waited from the prophylactic cleaning of the rectum to the beginning of the biopsy. The examiner will use a technique of disinfecting the 10% formaldehyde biopsy needle without manual contact by soaking the distal 3 cm of the needle directly into a vial containing the bactericidal solution between obtaining the different fragments. An individual bottle will be used for each patient

Control arm

controls at transrectal ultrasound guided prostate biopsy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy

The examiner will use a gauze soaked and saturated with iodopovidone and perform a mechanical friction motion on the anterior wall of the rectum, at least 5 times from one margin to another of the prostate laterally-laterally. A period of two (2) minutes shall be waited from the prophylactic cleaning of the rectum to the beginning of the biopsy. The examiner will use a technique of disinfecting the 10% formaldehyde biopsy needle without manual contact by soaking the distal 3 cm of the needle directly into a vial containing the bactericidal solution between obtaining the different fragments. An individual bottle will be used for each patient

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signature of the consent term;
• Agreement with the study follow-up protocol;
• Indication of biopsy due to increased PSA (> 2.5), abnormal rectal touch or patients under active surveillance protocol

Exclusion Criteria

• Existence of cognitive deficit that impedes the reading and comprehension of the EHIC;
• Allergy to ciprofloxacin or iodine

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Transplante Doutor Euryclides de Jesus Zerbini

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de Transplantes Euryclides de Jesus Zerbini

São Paulo, , Brazil

Countries

Brazil

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Other Identifiers

BIOPSY1

Identifier Type: -

Identifier Source: org_study_id