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 24 h prior to surgery Post‐operative: epidural analgesia withdrawn ≤ 12 h post‐operatively; surgical instrumentation of or dissection involving the urinary tract; delay in removal of IUC due to medical necessity; pelvic sepsis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 |