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 |
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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. |
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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 |
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Outcomes |
Primary outcomes:
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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. |