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. 2021 Mar 31;2021(3):CD012250. doi: 10.1002/14651858.CD012250.pub2

Pang 2015.

Study characteristics
Methods Design: prospective RCT conducted in China. The safety and efficacy of a circular stapler compared with conventional surgery. 56 participants prospectively enrolled from the Department of Urology at Huainan Chaoyang Hospital.
Ethical approval: not stated
Consent: participants provided written informed consent.
Duration of study: not stated
Participants Inclusion criteria: men with redundant prepuce or phimosis.
Exclusion criteria: other diseases such as urinary tract infection, leukemia and bleeding disease.
Baseline characteristics: participant characteristics comparable between groups in age, phimosis and redundant prepuce. Mean age 21.3 (SD 2.5) years, ranging from 12 to 61 years.
Interventions Providers: not clearly described.
Intervention group (stapler): 28 participants. Penis prepared and disinfected using povidone‐iodine and procedure performed according to a defined protocol.
Follow‐up: Not reported
Control group (conventional surgical): 60 participants. Sterile skin preparation, injection base penile ring block, dorsal slit circumcision procedure performed.
Follow‐up: Not reported
Outcomes Primary outcomes:
  • operative time (minutes)

  • pain score (24 hours after surgery)

  • blood loss volume (mL)

  • postoperative complications (edema, infection, deformity)

  • healing time (days)

  • satisfaction

  • treatment costs

Funding sources Not stated
Declarations of interest Not stated
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details given.
Allocation concealment (selection bias) Unclear risk No details given.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not described. Participants were likely aware of interventions they had received.
Blinding of outcome assessment (detection bias)
Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction) High risk Not described. Providers were likely aware of interventions; outcome assessment for subjective outcomes may have been affected by lack of blinding; high risk of detection bias.
Blinding of outcome assessment (detection bias)
Objective outcomes (operative time) Low risk Not described. A lack of blinding was unlikely to have resulted in detection bias for the outcome 'operation time,' which we considered objective.
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing data or missing data had limited effect on results.
Selective reporting (reporting bias) High risk No study protocol and, therefore, it was unclear whether there may have been selective outcome reporting. In addition, the pain outcome was not reported.
Other bias Low risk No other biases identified.