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

Li 2014.

Study characteristics
Methods Design: prospective RCT conducted in China. The safety and efficacy of a new male circumcision technique involving the use of a circular stapler was investigated. 249 participants prospectively enrolled from Department of Urology, Second Affiliated Hospital of Wenzhou Medical University.
Ethical approval: not stated
Consent: participants provided informed consent.
Duration of study: May 2013 to December 2013
Participants Inclusion criteria: men with redundant prepuce or phimosis, who intended to have circumcision.
Exclusion criteria: acute urinary tract infection, occult penis, severe foreskin penis head adhesion, too short foreskin and long foreskin, history of neurologic or psychiatric disorders, leukemia, bleeding disorders and uncontrolled diabetes.
Baseline characteristics: participant characteristics comparable between groups in age, phimosis and redundant prepuce. Mean age of both groups combined was 26.94 (SD 6.25) years.
Interventions Providers: not described in detail.
Intervention group (stapler): 129 participants. Appropriate size of stapler device (Jiangxi Yuanshenglanghe Medical Equipment Company, China) ascertained and procedure performed according to defined protocol.
Follow up: pain assessed at 24 hours,  3rd and 30th day post‐procedure.
Control group (conventional): 120 participants. Dorsal slit circumcision procedure.
Follow up: pain assessed at 24 hours,  3rd and 30th day post‐procedure.
Outcomes Primary outcomes:
  • operation time (minutes)

  • pain score using VAS (intraoperative and 24 hours after surgery)

  • blood loss volume (mL)

  • postoperative complications (infection, edema, bleeding, wound dehiscence)

  • wound healing time (days)

  • penile appearance satisfaction (3 days and 1 month after surgery)

  • total treatment cost (Chinese Yuan)

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.
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) Unclear risk No study protocol and, therefore, unclear whether there may have been selective outcome reporting.
Other bias Low risk No other biases identified.