Rajan 2017.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: September 2008‐March 2010 |
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Participants |
Number of participants: 200 participants randomised into 2 groups Setting: tertiary teaching institute South India Country: India Population: women undergoing vaginal surgery Age (mean and SD): Group A: 50 ± 18; Group B: 48 ± 2.4 Inclusion criteria: all women undergoing vaginal surgery namely Ward Mayo operation; Manchester repair; vaginal hysterectomy and amputation of cervix Condition for hospitalisation: vaginal surgery Exclusion criteria: all women having pre‐operative positive urine cultures; elevated renal parameters (blood urea > 40 mg/dL, serum creatinine > 1 mg/dL); comorbid illness ‐diabetes; intra operative visceral injury; Kelly’s stitch and consent not given by patient Use of antibiotic prophylaxis: measured but not reported specifically |
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Interventions |
Group A (n = 100): removal of IUC and vaginal pack in 3 h Group B (n = 100): removal of IUC and vaginal pack in 24 h Size and type of catheter used (e.g. Foley 16F): not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: IUC removal 3 h after surgery Group B: IUC removal 24 h after surgery |
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Outcomes | Number of participants requiring recatheterisation Incidence of UTI Incidence of urinary retention |
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Definition of CAUTI or bacteriuria | “urinary infections defined as when microscopic examination of the urine revealed pus cells or when urine culture showed growth of pathogenic organisms” | |
Sponsorship/funding | “No external sources of funding” | |
Ethical approval | “The study was approved by institutional research board (IRB) of Jawaharlal Institute of Post‐graduate Medical Education & Research (JIPMER), Puducherry, India (EC Ref # 5_ 2008)” | |
Notes | Declarations of interest: “The authors declare that they have no competing interest” | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “They were randomised into two groups based on a computer‐generated randomization table." 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 possible given intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported. Likely microbiologist would have been blinded as to which samples were in the trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of any incomplete data |
Selective reporting (reporting bias) | Low risk | Outcomes reported in full |
Other bias | Low risk | Appears to be free from other sources of bias |