Durrani 2014.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: 1 September 2009‐31 July 2011 |
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Participants |
Number of participants: eligible, not reported; 320 randomised; 320 reported Setting: Peshawar Country: Pakistan Population: men Age (mean and SD): 71.32 ± 5.94 Inclusion criteria: patients with bladder outflow obstruction due to benign prostatic enlargement undergoing TURP Condition for hospitalisation: TURP Exclusion criteria: large post‐void urine volume; urethral stricture; patients undergoing simultaneous internal urethrotomy and TURP; comorbidities such as uncontrolled diabetes mellitus, spinal cord problem, cerebro‐vascular accident or any condition that might result in neurogenic urinary bladder; intra‐operative complications like capsular or bladder perforation, severe haemorrhage during or immediately after surgery Use of antibiotic prophylaxis: cephalosporin 1 gm was administered IV at the time of induction of anaesthesia |
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Interventions |
Group A (n = 163): delayed IUC removal (conventional) Group B (n = 157): early IUC removal Size and type of catheter used: 22 Fr catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: removal of IUC after > 1 day post‐op (usually 4th or 5th day) Group B: removal on the 1st day post‐op |
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Outcomes | Mean catheter removal day Mean length of hospital stay in group Recatheteristaion Mild dilutional hyponatraemia Emergency re‐admission Reoperation, clot evacuation and diathermy of bleeding/oozing points UTI |
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Definition of CAUTI or bacteriuria | Not reported | |
Sponsorship/funding | Not reported | |
Ethical approval | “Written informed consent was taken from all the patients before including them in the study.” | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Patients were divided into the two groups by randomly selecting from a pile of sealed opaque envelopes containing assignment as A or B group as the patients came and were included in the study.” Comment: adequate method of randomisation |
Allocation concealment (selection bias) | Low risk | Quote: “Sealed opaque envelopes were kept in a box in equal proportion and patients were asked to select one sealed envelope. Fifty envelopes with 25 for each group, A and B, were kept in the box initially and when 10 would remain, another 50 with the same proportions would be added.” Comment: adequate method of concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely participants were not blinded as to when their catheter was removed. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “The box was kept locked all the time and under the supervision of the principal investigator … a doctor who did not know the actual grouping of patients collected all the data.” Comment: adequate method of blinding of outcome assessment |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Assumed microbiologist was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No report number of patients excluded or number of dropouts. All participants who were included in the study completed the study. |
Selective reporting (reporting bias) | Low risk | Outcomes mentioned in methods are reported in results section. Protocol was not available for assessment |
Other bias | Low risk | No other sources of bias apparent |