Lang 2020.
| Study characteristics | ||
| Methods |
Study design: RCT Setting: The Christ Hospital, Cincinnati, USA Dates study conducted: November 2014‐August 2017 |
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| Participants |
Population: women Inclusion criteria: all women presenting to The Christ Hospital for gynaecologic surgery anticipated to require at least a 1‐night stay and who would be expected to have an IUC overnight Condition for hospitalisation: benign gynaecological surgery Exclusion criteria: patients with a current UTI being treated with antibiotic(s), or anticipated to undergo concomitant prolapse or incontinence surgery, or a pre‐operative diagnosis of gynaecologic malignancy, or a history of chronic IUC use, or a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged post‐op catheter use Number of participants: 200 eligible; 200 randomised; 164 reported Age (mean and SD): 44.4 ± 8.8 years Use of antibiotic prophylaxis: all participants received pre‐operative antibiotics with either The American College of Obstetricians and Gynecologists approved dosing of cefazolin (78%) or a combination of gentamicin and clindamycin (22%) with no difference between fast‐track or conventional Foley management groups (P = 0.54). |
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| Interventions |
Group A (n = 81): IUC removal 4‐h post‐op (“fast track”) Group B (n = 83): IUC removal day 1 post‐op (“conventional”) Size and type of catheter used: not reported Study definition of short‐term catheterisation (days): 1 day Intended duration of catheterisation for each group: Group A: 4 h post‐op Group B: 1 day post‐op |
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| Outcomes | Median dwell time for Foley catheters Voiding trial failure rate Incidence of UTI |
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| Definition of CAUTI or bacteriuria | Not reported | |
| Sponsorship/funding | Not reported | |
| Ethical approval | The institutional review board at The Christ Hospital approved this trial investigating 2 catheter management strategies among postgynaecologic surgery patients | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Permuted block randomization was performed, via “Microsoft Excel,” with a block size of 4 used to ensure balanced enrolment.” Comment: adequate method of restricted randomisation |
| Allocation concealment (selection bias) | Low risk | Quote: “The allocation sequence was concealed from the researcher enrolling patients through the use of sequentially numbered, opaque sealed envelopes” Comment: adequate allocation method |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Unlikely 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. Assumed microbiologist was blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "In addition, our study had a dropout rate of 38%. This is likely due to the fact that postoperative follow‐up was obtained via phone calls and not in‐person at the time of a
clinic visit." Comment: 124 participants included in the final analysis from the original 200 participants who were randomised. Large dropout due to loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Outcomes mentioned in methods are reported in results section. Protocol not available for assessment |
| Other bias | Low risk | Appears to be free from other sources of bias |