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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

Coyle 2015.

Study characteristics
Methods Study design: RCT
Dates study conducted: January 2012‐July 2013
Participants Number of participants: 46 eligible; 44 randomised (22 in each arm); 35 reported (7 participants in Group A did not receive intervention, 1 participant from Group A excluded from analysis (catheter reinserted); 2 participants from Group B excluded from analysis due to medical necessity)
Setting: Galway
Country: Ireland
Population: mixed (30 male, 14 female)
Age (mean): A 63.5; B 62
Inclusion criteria: 18 years old; competent to consent for research purposes; plan to undergo elective transabdominal colectomy, proctectomy or coloproctectomy with post‐operative epidural analgesia
Condition for hospitalisation: elective transabdominal colectomy, proctectomy or coloproctectomy
Exclusion criteria:
Pre‐operative: prior surgery to lower urinary tract; pre‐existing lower urinary tract disease; intermittent self‐catheterisation; neurogenic bladder; pregnancy; prior transabdominal pelvic surgery; known enterovesical fistula; planned; synchronous urinary tract surgery; anticholinergic therapy; IPSS ≥ 20; urethral catheter indwelling > 24 h prior to surgery
Post‐operative: epidural analgesia withdrawn ≤ 12 h post‐operatively; surgical instrumentation of or dissection involving the urinary tract; delay in removal of IUC due to medical necessity; pelvic sepsis at surgery; unexpected finding of entero‐ or rectovesical fistula at surgery; premature dislodgement of urethral catheter; failed epidural catheterisation
Use of antibiotic prophylaxis: not reported
Interventions Group A: urethral catheter removal 48 h post‐op (n = 13)
Group B: urethral catheter removal within 12 h of withdrawal of epidural analgesia (n = 20)
Size and type of catheter used: not reported
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
A: 48 h
B: 12 h after withdrawal of epidural analgesia (median duration of catheterisation was 85.5 h)
Outcomes Development of post‐operative urinary retention (total)
Bacteriuria (UTI)
Definition of CAUTI or bacteriuria Symptomatic or asymptomatic bacteriuria used. Unclear which definition is used however
Sponsorship/funding None
Ethical approval “Ethical approval given by the local Clinical Research Ethics Committee (CA 661)”
Notes In total, 9 participants (20.5%) were excluded from analysis during the post‐operative period. In SG1, 7 patients were excluded due to the following reasons: premature accidental dislodgement of IUC (n = 2); epidural catheter dislodgement < 24 h post‐operatively (n = 2), unplanned instrumentation of the urinary tract at surgery (n = 1); IUC re‐inserted post‐operatively due to oliguria (n = 1); withdrawal of consent for patient participation (n = 1). In SG2, 2 participants were excluded due to IUC removal being delayed as a result of medical necessity.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “… were randomised using a computer generated randomisation system”
Comment: adequate method of randomisation
Allocation concealment (selection bias) Low risk Quote: “The operator was blinded as to the allocated arm, which was contained in a sealed envelope, at the time of catheter insertion.”
Comment: adequate method of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported – unlikely it was possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Blinding of microbiological outcome (detection bias) Low risk Not reported. Likely however that samples were sent to a laboratory where the microbiologist would be unaware of the study
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Flowchart indicates that group A reported on 14 patients and group B on 20 patients – but in table there are only 13 patients in group A
Selective reporting (reporting bias) Low risk All outcomes in methods are reported in full in results.
Other bias Low risk Appears to be free from other sources of bias