Gong 2017.
Study characteristics | ||
Methods |
Study design: RCT Dates study conducted: February 2012‐April 2015 |
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Participants |
Number of participants: 210 eligible; 198 randomised; 198 reported Setting: First Affiliated Hospital of Chongqing Medical University (FAH‐CMU) Country: China Population: women Age (mean ± SD): A 46.14 ± 8.33; B 45.70 ± 9.63 Inclusion criteria: patients with cervical cancer FIGO stage IB‐IIB Condition for hospitalisation: radical hysterectomy Exclusion criteria: patients were excluded if they had urinary incontinence, interstitial cystitis, cognitive impairment or difficulties in completing the training sheet Use of antibiotic prophylaxis: not reported |
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Interventions |
Group A (n = 70): IUC for 48 h with intermittent clamping Group B (n = 128): IUC for 48 h without intermittent clamping Size and type of catheter used: not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: A: 48 h B: 48 h |
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Outcomes | Recatheterisation Residual urine volume 24 h after removal CAUTI Duration of first catheterisation (days) |
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Definition of CAUTI or bacteriuria | Symptomatic UTI was defined as bacteriuria with fever, frequent or painful urination or burning on urination | |
Sponsorship/funding | None | |
Ethical approval | The Institutional Review Board of Chongqing Medical University approved the study (File No.: 2012045), and all patients provided written informed consent. | |
Notes | In the clamping group, bladder reconditioning was performed 2 days before IUC removal. The participants did the intermittent clamping, while the nurses performed the catheter insertion and removal. A designed training sheet was handed to the participants, who were educated on how to clamp the IUC and finish the sheet. In detail, IUCs were clamped for 4 h or until participants had urination desire, followed by a 5‐min urinary drainage, a cycle repeated in the daytime for 2 days. The schedule was chosen because it appeared to mimic a normal pattern of bladder filling and emptying | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "All patients were randomised on 2:1 using a computer‐generated list into two groups, the clamping group and the control group" Comment: adequate method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Both the researchers and the patients were not blind to the group assignment due to the procedure of the study" Comment: not possible to blind participants due to type of intervention |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Outcome assessors were not blinded in the study..." Comment: outcome assessors not blinded |
Blinding of microbiological outcome (detection bias) | Low risk | Urine samples would be sent to a laboratory where the allocation of a participant would not be known |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Five patients were excluded from the clamping group (three failed to record the training sheet, two had severe urine leakage during clamping because of the unfitted catheters and the catheters were removed without training). Seven patients in the control group dropped out because the catheters were removed in other hospitals and the data were missing.” Comment: adequate reasons for exclusion |
Selective reporting (reporting bias) | Low risk | Outcomes mentioned under Methods section are reported in Results. All outcomes expected from the objective of this trial are reported. |
Other bias | Low risk | Appears to be free from other sources of bias |