Huo 2015.
| Study characteristics | ||
| Methods |
Design: prospective RCT conducted in China. Safety and efficacy of a new male circumcision technique involving a circular stapler investigated. 180 participants were prospectively enrolled from Department of Urology, Guangxi Zhuang Autonomous Region People's Hospital. Ethical approval: The People's Hospital of Guangxi Zhuang Autonomous Region Ethics Committee Consent: participants provided written informed consent. Duration of study: enrollment December 2013 to August 2014 |
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| Participants |
Inclusion criteria: adult men with redundant prepuce or phimosis, who had the indication of circumcision (per 2014 Guidelines for the Diagnosis and Treatment of Urological Diseases in China). For the selection criteria, see "Guide to the Diagnosis and Treatment of Urology in China" edited by Na Yanqun. (那彦群, 叶章群, 孙颖浩, 等主编. 中国泌尿外科疾病诊断治疗指南. 第 1 版. 北京: 人民卫生出版社, 2014. 406–7). Exclusion criteria: urinary tract infection or balanoposthitis; severe adhesion between the inner foreskin layer and the glans, or short frenum and coagulation disorder; diabetes mellitus or other lying diseases that influenced the effect of surgery. Baseline characteristics: comparable between groups. No statistically significant difference existed between age, phimosis and redundant prepuce of 2 groups. Circumcision device group mean age was 30.4 (SD 9.1) years, traditional method mean age was 31.7 (SD 11.7) years |
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| Interventions |
Providers: experienced urologists. Intervention group (stapler): 120 participants. The penis was prepared and disinfected using povidone‐iodine. Local anesthesia performed with 1% lidocaine. Appropriate size of stapler device (Jiangxi Yuanshenglanghe Medical Equipment Company, China) ascertained by measuring diameter of penis and procedure conducted according to a defined protocol. Dressing change and evaluation on wound healing was performed on the 1st, 4th and 7th day after surgery. Follow‐up: pain assessed 24 hours post‐procedure. Foreskin oedema assessed on day 7, satisfaction assessed on day 3 and 30 post‐procedure. Control group (conventional): 60 participants. Dorsal slit circumcision procedure. Follow‐up: pain assessed 24 hours post‐procedure. Foreskin oedema assessed on day 7, satisfaction assessed on day 3 and 30 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) | Low risk | Used a random number table. |
| Allocation concealment (selection bias) | Unclear risk | No details provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. Participants were likely aware of interventions 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; rated at high risk of detection bias. |
| Blinding of outcome assessment (detection bias) Objective outcomes (operative time) | Low risk | Not described. A lack of blinding is 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; unclear whether there may have been selective outcome reporting. |
| Other bias | Low risk | No other biases identified. |