Liang 2009.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: July 2007‐January 2008 |
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Participants |
Number of participants: 162 eligible; 150 randomised; 150 reported Setting: Taiwan Population: women Age (mean ± SD): A 43.7 ± 3.9; B 45.7 ± 3.5; C 45.7 ± 5.8 Inclusion criteria: consenting women undergoing laparoscopic‐assisted vaginal hysterectomy. Included uterine myoma, adenomyosis, tubo‐ovarian abscess, intra‐epithelial neoplasia of the cervix, grade 3 and intractable hemorrhagic Condition for hospitalisation: hysterectomy Exclusion criteria: patients that had pelvic organ prolapse or urodynamic stress incontinence or found with bacteriuria form pre‐operative urinalysis or clinically adverse urinary symptoms such as dysuria, frequency of micturition, urgency stress incontinence or obstructive voiding symptoms Use of antibiotic prophylaxis: IV prophylactic antibiotics consisting of cefazolin 500 mg after induction of general anaesthesia |
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Interventions |
Group A (n = 50): no IUC Group B (n = 50): IUC removed after 1 day Group C (n = 50): IUC removed after 2 days Size and type of catheter used: indwelling Foley catheter Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: no IUC use post‐op B: IUC removed 1 day post‐op (removal at 7 am‐8 am) C: IUCremoved 2 days post‐op (removal at 7 am‐8 am) |
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Outcomes | UTI Urinary retention Duration of catheter time |
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Definition of CAUTI or bacteriuria | UTI was defined as a positive urine culture with colonies of bacteria > 105 organisms/μL. However, treatment was instituted for positive urine cultures only if the patient had adverse urinary symptoms or post‐op pyrexia (> 38 °C). | |
Sponsorship/funding | This work was supported by Medical Research Project Grant CMRPG 360291 and BMRP 412 from Chang Gung Memorial Hospital | |
Ethical approval | The ethics committee of the hospital approved the study protocol (No. 95‐1179B). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Randomly allocated …” Comment: unclear as to how randomisation was actually performed |
Allocation concealment (selection bias) | Low risk | Quote: “Randomization was achieved by selection of sealed envelopes, which were opened just before surgery. When patients’ number in each group reached 50, we ended the patient collection.” Comment: adequate method of concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Likely not possible to blind participants |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Unlikely that microbiologist knew participants belonged to the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported |
Selective reporting (reporting bias) | Low risk | All outcomes reported in full in methods and results sections |
Other bias | Low risk | Appears to be free from other sources of bias |