Wu 2010.
Methods | Study design: two‐armed parallel, randomised controlled trial Study setting: University Hospital in People's Republic of China Study duration: March 2007 to July 2008 |
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Participants | Thirty‐one women with (FIGO) stages IB1 to IIA cervical cancer were randomly to undergo standard radical hysterectomy (N = 15) and nerve‐sparing radical hysterectomy (N = 16). All participants had no obvious abnormal bladder function prior to operation determined by urodynamic study. However, only 29 women completed the study and included in the analysis. | |
Interventions | Control group: classical Piver III radical hysterectomy. Intervention: nerve‐sparing radical hysterectomy, as described by Fujii 2007; and Fujii 2008 All procedures were carried out via laparotomy approach |
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Outcomes |
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Notes | Information was insufficient for assessment of whether an important risk of bias existed. | |
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 quality of life is likely to be influence by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The authors stated that participants were assessed blindly by a direct program control (DPC), but further description of blinding is not included |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were analysed for all outcomes. No missing data |
Selective reporting (reporting bias) | Low risk | All potential relevant outcomes were reported |
Other bias | Unclear risk | Information was insufficient for assessment of whether an important risk of bias existed. |
DFS: disease‐free survival FIGO: Federation of Gynecology and Obstetrics