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 |
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| 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. |
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| 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. |
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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. |
| 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. |