Chen 2014.
Methods | Study design: two‐armed parallel, randomised controlled trial Study setting: University Hospital in People's Republic of China Study duration: March 2010 to March 2014 |
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Participants | Participants were 65 women with stage Ia2 to Ⅱa2 cervical cancer (35 in nerve‐sparing group and 30 in standard operation group). Exclusion criteria included a history of voiding dysfunction, previous pelvic radiotherapy, previous pelvic reconstruction, and brain/spinal cord diseases. | |
Interventions | Control: Querleu and Morrow type C, standard laparoscopic radical hysterectomy Intervention: Querleu and Morrow type C, nerve‐sparing laparoscopic radical hysterectomy All women received cisplatin‐based adjuvant chemotherapy in 1–2 courses before surgery depending on tolerance and response. |
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Outcomes |
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Notes | Of 65 women, only 16 women underwent bladder function assessment evaluated by the urodynamic study at 6‐12 months following operation. | |
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 postoperative urinary symptoms and quality of sexual life assessed by a questionnaire are likely to be influence by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement regarding the blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only 16 women participants (24.6%) in both arms underwent urodynamic study to evaluate postoperative bladder functions (7 or 23.3% in nerve‐sparing group and 9 or 25.7% in standard surgery group), which was one of the primary outcomes of interest in this study |
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. |