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

Rajan 2017.

Study characteristics
Methods Study design: RCT
Dates study conducted: September 2008‐March 2010
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
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
Outcomes Number of participants requiring recatheterisation
Incidence of UTI
Incidence of urinary retention
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