Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202695114430 Date of Approval: 03/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title rectal preparation before prostate biopsy: Normacol versus Povidone iodine versus placebo
Official scientific title rectal preparation before prostate biopsy: Normacol versus Povidone iodine versus placebo
Brief summary describing the background and objectives of the trial Prostate cancer is the world's leading cancer in men and the second leading cause of cancer death in men after lung cancer. Its diagnosis is based on histological evidence provided by a prostate biopsy (PB). This biopsy is performed by transrectal ultrasound guided in a systematized way and preceded by an antibiotic prophylaxis based on fluoroquinolones (FQ) recommended by all learned societies. Prostate biopsy is associated with complications, especially infectious ones, ranging from 1 to 4% according to the literature. Due to the significant increase in the frequency of betalactamase-secreting bacteria in our country, the rate of complication rate is increasingly important. The role of pre-biopsy screening for FQ-resistant bacteria is currently being evaluated. In view of the hypothesis put forward by different studies concerning the contamination of the prostatic parenchyma by germs coming from the rectal flora during transrectal prostate biopsy, several means of rectal preparation have been proposed in order to minimize the contamination of the puncture zone before the biopsy and to decrease the rate of septic complications. In this study, we propose to compare two types of rectal preparation before prostate biopsy and to evaluate their interest in reducing the rate of infectious complications. Objective(s) of the work To evaluate the contribution of two methods of rectal preparation in reducing the incidence of post-PB infectious complications. To study the prevalence of urinary and digestive carriage of FQ-resistant bacteria in patients proposed for prostate biopsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2019
Actual trial start date
Anticipated date of last follow up 07/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No rectal preparation 10 min In this group, no rectal preparation was done before the prostate biopsy 40 Placebo
Experimental Group Povidone iodine 10 cc 30 min the patient had a rectal preparation with povidone-iodine (10 cc in 90 cc saline) 40
Experimental Group Normacol 1 flacon of normacol 30 min he patient had a rectal preparation with Normacol on the morning of the procedure 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with a justified indication for biopsy: *Those with a suspicious digital rectal exam( nodular, hard) *and/or those with an initial serum PSA level above 4 ng/ml - Patients whose life expectancy is greater than 10 years -Patients with a history of prostate biopsy. - Patients with a bladder catheter. - Patients with a contraindication to ciprofloxacin (history of tendinopathy or hypersensitivity to a product of the quinolone family). - Patients with a contraindication to prostate biopsy (uncorrected coagulation abnormality, untreated urinary tract infection). - Patients with severe renal or hepatic insufficiency. - Patients with a life expectancy of less than 10 years. - Patients with missing data on the medical record Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/12/2018 Local ethics committee
Ethics Committee Address
Street address City Postal code Country
Rue jabbari tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the occurrence of infectious signs and prostatitis during the 15 days following the b prostate biopsy. 15 days
Primary Outcome Occurrence of bleeding complication 15 days
Secondary Outcome prevalence of urinary and digestive carriage of germs resistant to fluoroquinilones rectal swab and urine culture
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Departement of urology Rabta Hospital Rue Jabbari tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Moez Rahoui Rue jabbary Tunis 1007 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rabta Hospital Rue jabbari tunis 1007 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mourad daly kheireddine daly099@gmail.com +21628121424 rue jabbary
City Postal code Country Position/Affiliation
tunis 1007 Tunisia Department of urology
Role Name Email Phone Street address
Scientific Enquiries Ben Rhouma S Sami rmoez099@gmail.com +21628121424 rue jabbary
City Postal code Country Position/Affiliation
tunis 1007 Tunisia Urology Departement
Role Name Email Phone Street address
Scientific Enquiries Nouira Yassine rmoez099@gmail.com +21628121424 Rue jabbari
City Postal code Country Position/Affiliation
tunis 1007 Tunisia Urology Department
Role Name Email Phone Street address
Public Enquiries Moez Rahoui rmoez099@gmail.com +21628121424 Rue jabbari
City Postal code Country Position/Affiliation
tunis Tunisia Urology Departement
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol 2 years Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information