Roh 2015.
| Methods | Study design:two‐armed parallel, randomised controlled trial Study setting: multicentre, two‐armed parallel, randomised controlled trial conducted in University Hospitals and Tertiary Hospital in Korea Study duration: March 2003 to November 2005 |
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| Participants | Ninety‐two women with cervical cancer stage IA2 to IIA were randomly assigned for surgical treatment with standard radical hysterectomy or nerve‐sparing radical hysterectomy, and 86 women were finally included in the analysis. Exclusion criteria were neuroendocrine histology, pathologically proven distant metastasis, history of psychiatric disease, preoperative urinary dysfunction, and another coexisting malignancy. Women with an adequate follow‐up duration of more than one year after the surgery were included in the analysis (86 women; 40 in standard surgery and 46 in nerve‐sparing surgery) |
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| Interventions | Control group: classical Piver III radical hysterectomy () Intervention group: nerve‐sparing radical hysterectomy All procedures were carried out via laparotomy approach. Type of radical hysterectomy was additionally provided by contact author of this study (Park 2016 [pers comm]) |
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| Outcomes | Bladder function recovery: time to postvoid residual urinary volume (PVR) <50 mL and bladder function (PVR, maximal urethral closure pressure (MUCP), maximum flow rate (MFR), average flow rate (AFR), bladder compliance, and detrusor pressure at maximum flow) assessed by urodynamic study performed at 1, 3, and 12 months following operation; Subjective urinary symptoms using International Prostate Symptom Score (IPPS); Ten‐year disease‐free and overall survival. |
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| Notes | The analyses performed in this study was not based on an intention‐to‐treat basis as only participants with follow‐up duration of more than one year after surgery were included in the final analyses. Estimation of disease‐free survival was based unadjusted hazard ratio. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No statement regarding the method used to generate the allocation sequence |
| Allocation concealment (selection bias) | Unclear risk | No statement regarding the method used to conceal the allocation sequence |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No statement regarding the blinding of participants and personnel. Some outcomes such as subjective bladder dysfunction assessed by a questionnaire is likely to be influence by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The authors stated that there was one urologist responsible for assessing the results of urodynamic study without any clinical information, but further description of blinding is not included |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Of 92 participants randomised, four participants lost to follow‐up (2) or discontinued intervention (2), corresponding to a rate of incomplete outcome data of approximately 4.3% thus this is unlikely to influence the effect of treatment assigned |
| Selective reporting (reporting bias) | Low risk | All potential relevant outcomes were reported |
| Other bias | High risk | The analyses performed in this study was not based on an intention‐to‐treat basis. |