Ahmed 2014.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: April 2010‐December 2012 |
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Participants |
Number of participants: 233 eligible; 221 randomised; 221 reported Setting: Ismailia Country: Egypt Population: women Age (mean (SD)): A 59.1 (8.3); B 58.3 (6.9); C 61.3 (10.5) Inclusion criteria: women undergoing total abdominal hysterectomy with or without bilateral salpingo‐oophorectomy for various benign gynaecological diseases (uterine fibroids, abnormal uterine bleeding) Condition for hospitalisation: hysterectomy Exclusion criteria: known history of neurological disorders, women who had UTI pre‐operatively confirmed by urine analysis ± culture and sensitivity, women for whom a complicated procedure was encountered during hysterectomy so that an IUC had to be kept post‐operatively on surgeon’s decision, women had spinal anaesthesia by choice or when general anaesthesia was contraindicated, women who had urge incontinence, women who refused to participate in study Use of antibiotic prophylaxis: on the morning of surgery, all participants received a single dose of prophylactic antibiotic in the form of ceftriaxone 1 g IM |
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Interventions |
A (n = 73): IUC removed immediately after surgery B (n = 81): IUC removed 6 h post‐operatively C (n = 67): IUC removed 24 h post‐operatively Size and type (e.g. silver‐coated/PTFE) of catheter used: 12F Foley catheter, latex Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: immediately after surgery; B: 6 h post‐operatively; C: 24 h post‐operatively |
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Outcomes | Urine retention and re‐catheterisation (%) Symptomatic UTI (%) Post‐operative urine culture First ambulation Hospital stay Urinary symptoms 1 week post‐operatively Fever Dysuria Frequency Urgency Loin pain Positive urine culture 1 week post‐operatively |
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Definition of CAUTI or bacteriuria | The diagnosis of symptomatic UTI was based on the following criteria: significant bacteriuria with at least one of the following symptoms; dysuria, frequency of micturition, urgency, suprapubic pain or burning sensation at micturition | |
Sponsorship/funding | Not reported | |
Ethical approval | The study was carried out in accordance to the ethical principles for medical research involving human subjects included in Helsinki declaration and was approved by the Suez Canal University (SCU) Ethical Committee. | |
Notes | All participants had continuous bladder drainage during the surgery The time to ambulation was defined as the period between the end of surgery and the time when the patient first walked supported by a nurse or relative. The length of hospital stay was defined as the time between the end of surgery and hospital discharge Patients were recatheterised with a disposable female catheter if they were not able to empty their bladders 6 h after catheter removal. If unable to empty bladder 12 h after catheter removal, an indwelling catheter was inserted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “The remaining 221 women were divided into three groups by simple randomization using computer‐generated random numbers” Comment: adequate method of randomisation used |
Allocation concealment (selection bias) | Unclear risk | Not reported Comment: probably not done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. Comment: unlikely blinding was possible due to the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported Comment: no information given. Outcomes such as urinary symptoms could be affected by detection bias |
Blinding of microbiological outcome (detection bias) | Low risk | Not reported Comment: likely urine samples were sent to a laboratory where the microbiologist would not know which patients were in the trial |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: “Twelve patients were finally excluded from the study; five patients had intra‐operative complications (iatrogenic bladder injury)… while seven did not complete the postoperative follow‐up…” Comment: patients should have been analysed according to ITT analysis of patients lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes have been accounted for in both the methods and results |
Other bias | Low risk | Appears to be free from other sources of bias |