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

March 17, 2020 updated by: Hospital de Transplante Doutor Euryclides de Jesus Zerbini

A Randomized Controlled Trial to Investigate the Infectious Outcomes of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of Needle Tip During Transrectal Ultrasound Guided Prostate Biopsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1257

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01401901
        • Hospital de Transplantes Euryclides de Jesus Zerbini

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

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PVPI intervention
rectal cleansing and disinfection of the needle tip at transrectal ultrasound guided prostate biopsy
Other: 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
No Intervention: Control arm
controls at transrectal ultrasound guided prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious complications
Time Frame: 1 week
compare the infectious outcomes of intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate predictive factors of infectious complications after prostate biopsy.
Time Frame: 1 week
evaluate predictive factors of infectious complications after prostate biopsy.
1 week

Collaborators and Investigators

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

Sponsor

Hospital de Transplante Doutor Euryclides de Jesus Zerbini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 31, 2017

Primary Completion (Actual)

July 24, 2019

Study Completion (Actual)

July 24, 2019

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOPSY1

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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