Faecal screen pre prostate biopsy to reduce complications
Research type
Research Study
Full title
A randomized controlled trial to compare standard prophylaxis versus targeted prophylaxis through faecal screening to reduce infectious complications in prostate biopsy
IRAS ID
139359
Contact name
Ifeoma Ekwueme
Contact email
Sponsor organisation
University of Portsmouth
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
A randomized controlled trial to determine whether specific antibiotic prior to biopsy through faecal screening pre - prostate biopsy will lead to reduced infectious complications post biopsy.
Various studies have reported a reduced cost implication when targeted approach to prophylaxis is used prior to prostate biopsy. There are still unresolved issues in preventing infectious complications associated with biopsies taken from the prostate gland via the rectum. There is still evidence of inconsistency and lack of an appropriate laboratory screening method used by the studies already done in this area. The timing of the faecal screen for specific antibiotic prior to biopsy to be employed is very crucial, adequate time for laboratory result to be available is also crucial for targeted approach to be clinically useful. All available studies where targeted prophylaxis was used had the problems of small sample size and inappropriate randomization. Two studies that did randomization used a small sample size of fewer than 500 participants. There is also inconsistency in the follow strategy employed by all available studies.
The proposed study will determine whether specific antibiotic prophylaxis through faecal screening before prostate biopsy will lead to reduced infectious complications after biopsy through a randomised controlled trial employing 867 prostate cancer patients from South West London area.
The study will attempt to address the issue of small sample size and inappropriate randomization. It will also ensure a better strategy of following up participants to ensure any infective complication is noted. It will also attempt to use a more standardized laboratory method of screening to guide a choice of antibiotics that will replace fluoroquinolone where patients rectal flora are found to be resistant.REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1142
Date of REC Opinion
14 Jul 2015
REC opinion
Unfavourable Opinion