Suprasert 2002.
Study characteristics | ||
Methods | Study design: a prospective randomised study Study setting: Chiang Mai University Hospital in Thailand Study duration: September 1998 to June 1999 |
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Participants | 81 stage IB1‐IIA cervical cancer patients who underwent radical hysterectomy with pelvic lymphadenectomy (RHPL). At the end of the RHPL operation, the participants were allocated immediately into the intermittent self‐catheterisation (N=38) or the suprapubic catheterisation (N=33) group before abdominal closure. Exclusion criteria included abnormal preoperative bladder function or urinary analysis, urinary tract infection more than 2 times per year, history of renal stone, bladder calculi, urinary incontinence, intraoperative bowel or urinary tract complication, and inability to perform Intermittent self‐catheterisation (ISC). |
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Interventions | ‐ Control group: suprapubic catheterisation Suprapubic catheter was placed through a small bladder incision and exited through a separated skin incision. The catheter in this group was clamped on day 7 postoperatively for 4 hours and was released after self‐voiding to check the post voiding residual (PVR) urine. ‐ Intervention group: intermittent self‐catheterisation (ISC) The ISC group was managed by indwelling transurethral Foley’s catheter for 7 days. On day 6, the patient was instructed to do ISC until she could confidently perform by herself. When the Foley’s catheter was removed on day 8, the ISC was performed every 4 hours after each voiding and the PVR urine was recorded. ‐ In both groups, ISC and SPC were discontinued when the PVR was < 75 ml for 2 consecutive voids. |
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Outcomes | ‐ Febrile morbidity ‐ The voiding time (days) ‐ Rate of urinary tract infection |
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Notes | ‐ Urine analysis was performed weekly until the ISC or SPC was discontinued. ‐ Bacteriuria was defined as urinary culture showed the organism more than 105 colonies/mL. ‐ Prolonged bladder dysfunction was defined as the voiding time was longer than 30 days. ‐ Febrile morbidity was defined as two consecutive oral temperatures ≥ 38˚ C, at least 6 hours apart excluding the first 24 hours after operation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Assigned by computerised randomisation |
Allocation concealment (selection bias) | Low risk | Sealed in the envelope |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were not blinded to the intervention that they received. However, the outcomes of interest were unlikely to be affected by lack of blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No statement regarding the blinding of outcome assessment. However, the outcomes of interest were unlikely to be affected by lack of blinding of outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up |
Selective reporting (reporting bias) | High risk | No data on rate of spontaneous voiding recovery 1 week after surgery, QoL, post‐void residual urine volume at 1, 6 and 12 months after surgery, or subjective urinary symptoms were reported. |
Other bias | Low risk | No information indicating an important risk of other bias |