Ouladsahebmadarek 2012.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: 2009‐2010 |
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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 |
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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 |
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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 |
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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 |