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

Li 2010.

Study characteristics
Methods Design: prospective RCT conducted in China. The safety and efficacy of SR circumcision compared to conventional surgical procedures was investigated. 724 participants prospectively enrolled from the Department of Urology in Shaanxi Second People's Hospital.
Ethical approval: not described
Consent: participants provided written informed consent.
Duration of study: enrollment March 2008 to August 2009
Participants Inclusion criteria: males who wished to undergo circumcision.
Exclusion criteria: not described.
Baseline characteristics: participant characteristics comparable between groups. Circumcision device group, there were  282 participants in the 16 ‐ 35 years age group, 98 participants in the 36 ‐ 55 age group, 22 in the 56 ‐ 69 age group. For the traditional methods group, there were 219 participants in the 16 ‐ 35 years age group, 87 participants in the 36 ‐ 55 age group, 16 in the 56 ‐ 69 age group.
Interventions Providers: not described in detail.
Intervention group (SR): 402 participants (single or double date of visit). Appropriate size of SR was ascertained. Penis was disinfected using povidone‐iodine solution. Dorsal penile nerve block and circumferential block performed with 1% lidocaine.
Follow up: Pain assessed at 24 hours post‐procedure
Control group (conventional): 322 participants. A circumcision laser incision was used.  
Follow up: Pain assessed at 24 hours post‐procedure
Outcomes Postoperative observation items:
  • operation time (minutes)

  • postoperative pain scores (24 hours after surgery) using VAS

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

  • postoperative appearance satisfaction

  • postoperative sexual function

  • cost

Funding sources Unclear
Declarations of interest Unclear
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were randomized according to day/date of clinic visit.
Allocation concealment (selection bias) Unclear risk Not described.
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) Unclear risk No study protocol available and, therefore, it was unclear whether there may have been selective outcome reporting.
Other bias Low risk No other biases identified.