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. 2019 Feb 12;2019(2):CD012828. doi: 10.1002/14651858.CD012828.pub2

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
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.
Outcomes
  • Perioperative outcomes including blood loss, operative time, complications

  • Bladder functions (duration of the postoperative catheterisation, maximum flow rate (MFR), maximum detrusor pressure (MDP) evaluated by urodynamic study at 6 to 12 months following operation.

  • Intestinal functions and urinary symptoms assessed by a questionnaire at 1 year after the operation.

  • Quality of sexual life assessed by Female Sexual Function Index (FSFI) at 1 year after the operation.

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.