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

Benoist 1999.

Study characteristics
Methods Study design: RCT
Dates study conducted: January 1994‐June 1997
Participants Number of participants: eligible: not reported; 132 randomised; 126 reported
Setting: Paris
Country: France
Population: mixed
Age (mean (SD)): A 55 (18); B 56 (17)
Inclusion criteria: patients undergoing extensive rectal resection (total or subtotal proctectomy)
Condition for hospitalisation: rectal resection
Exclusion criteria: patients receiving pre‐operative therapeutic antibiotics; suspected bladder tumour or urinary tract malignancies; previous IUC that ended < 48 h before insertion of the current catheter
Use of antibiotic prophylaxis: as prophylaxis for bowel surgery, all patients were injected IV with a single dose of antibiotics on the induction of anaesthesia.
Interventions Group A (n = 64): IUC removal 1 day post‐op
Group B (n = 62): IUC removal 5 days post‐op
Size of catheter used: 14F catheter
Type of indwelling catheter: not reported
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
A: removal of IUC 1 day after surgery
B: removal of IUC 5 days after surgery
Outcomes AUR
Chronic urinary retention
UTI
Long‐term urinary complications
Patients undergoing total mesorectum excision
Definition of CAUTI or bacteriuria Urinary infection was diagnosed if a culture yielded > 105 cfu/mL, with or without clinical symptoms
Sponsorship/funding Not reported
Ethical approval “…which was approved by the hospitals ethics committee”
Notes AUR defined as absence of spontaneous micturition 12 h after catheter removal or after single intermittent catheterisation. Catheters were never clamped and were maintained on a closed drainage system.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “… patients were randomized into 1‐day or 5‐day urinary drainage groups according to the following computer‐generated randomization sequence.”
Comment: adequate method of randomisation
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported
Comment: unlikely blinding was possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Blinding of microbiological outcome (detection bias) Low risk Quote: “… urine samples from both groups were sent to a laboratory for culture”
Comment: cultures were sent to a laboratory so it is unlikely that the microbiologist knew which samples corresponded to patients in the trial.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "...1 patient died postoperatively, 2 had postoperative complications requiring early reoperation, 2 inadvertently removed catheters, 1 required prolonged urine output monitoring because of transient respiratory failure requiring prolonged artificial ventilation."
Comment: unclear what effect this has an the outcome of interest
Selective reporting (reporting bias) Low risk All outcomes reported in methods was reported in results. Protocol not available
Other bias Low risk Appears to be free from other sources of bias