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

Ouladsahebmadarek 2012.

Study characteristics
Methods Study design: RCT
Dates study conducted: 2009‐2010
Participants Number of participants: eligible, not reported; 200 randomised; 200 reported
Country: Iran
Population: women
Age (e.g. mean and SD): A 37.48 ± 8.85; B 39.48 ± 9.54
Inclusion criteria: elective abdominal hysterectomy or laparotomy for benign pathology (e.g. fibroma, abnormal uterine bleeding, chronic pelvic pain, ovarian cysts) under general anaesthesia; written informed consent
Condition for hospitalisation: abdominal hysterectomy or laparotomy
Exclusion criteria: patients who had intraoperative bleeding > 1 L; operation length > 2 h, severe endometriosis; dense pelvic adhesions; bladder suspension; underlying medical problems were excluded from the study
Use of antibiotic prophylaxis: cefazoline 1 g IV 30 min before surgery started and continued every 6 h until 2 doses
Interventions Group A (n = 100): Foley catheter removed immediately after surgery
Group B (n = 100): Foley catheter removed 24 h after surgery
Size and type of catheter used: 14 F Foley catheter with 15 cc balloon
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group: A 0 h; B 24 h
Outcomes Operation to discharge duration (days)
Time to ambulation (h)
Subjective measure of pain
Fever (> 38.5 °C)
Use of Nelaton catheter (for AUR)
Re‐use of indwelling Foley catheter
Urethral burn
Urine analysis
Symptomatic UTI
Dysuria at the beginning of urination
Definition of CAUTI or bacteriuria Mentions symptomatic UTIs but no definition given
Sponsorship/funding Vice Chancellor for Research, Tabriz University of Medical Sciences
Ethical approval The Ethics Committee of Tabriz University of Medical Sciences approved the study protocol
Notes We contacted the trial authors for missing data but no we received no reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “The randomization procedure was password protected, web based, using permuted blocks and stratified by study centre and invasive procedure.”
Comment: adequate method of randomisation. Randomisation was probably done
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. Unlikely that blinding is possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not specified
Blinding of microbiological outcome (detection bias) Low risk Microbiologists were assumed to be blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk All 200 participants completed the trial
Selective reporting (reporting bias) Low risk All outcomes are accounted for. Protocol was unavailable for assessment
Other bias Low risk Appears to be free form other sources of bias