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

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
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
Outcomes
  • Major postoperative complications including intestinal obstruction, urinary tract injury, deep vein thrombosis, lymphocyst formation, fever, and poor wound healing

  • Bladder function recovery: time to postvoid residual urinary volume (PVR) <100 mL and bladder function (PVR, MUCP, MFR, average flow rate (AFR),bladder compliance, and stress incontinence) assessed by urodynamic study at 6 to 12 months following operation.

  • Perioperative outcomes including operative time and amount of blood loss

  • Quality of life evaluated by Functional Assessment of Cervical Cancer Therapy (FACT‐Cx)

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