Department of Surgery and Anaesthesiology, School of Medicine, Moi University, Eldoret, Kenya.
J Urol. 2011 Nov;186(5):1923-7. doi: 10.1016/j.juro.2011.07.027. Epub 2011 Sep 23.
We established the safety and effectiveness as well as the acceptability of the Alisklamp® device for male circumcision among Kenyan men.
To qualify for this hospital based, prospective, interventional cohort study one needed to be an uncircumcised adult male who was HIV negative with no comorbid factors or genitourinary anomalies precluding circumcision. A total of 58 men were recruited from a population of 90. Outcome measures were the safety profile of Alisklamp and its efficiency and acceptability by participants.
All 58 procedures were completed without device malfunction, hemorrhage or undesirable preputial excision. Mean ± SD procedure time was 2.43 ± 1.36 minutes and mean device removal time was 15.8 ± 7.4 seconds. There were 2 adverse events, including mild edema and superficial wound infection related to poor hygiene in 1 case each. All men resumed routine activity immediately after circumcision. Of the 58 participants 25.9% experienced mild nocturnal erectile pains that required no medication. During 6-week followup all men were satisfied with the procedure, tolerated the device well and would recommend it to a friend.
Alisklamp has an excellent safety profile and excellent acceptability among men who undergo circumcision using the device. This technique is easy to teach and it would prove to be a handy device to scale up the rate of male circumcision. Based on these findings the device merits a comparative clinical trial.
我们在肯尼亚男性中确立了 Alisklamp® 装置进行男性割礼的安全性、有效性和可接受性。
要符合这项基于医院的前瞻性干预性队列研究的条件，需要符合以下条件的未割礼的成年男性，HIV 阴性，没有合并症因素或排除割礼的泌尿生殖系统异常。总共从 90 名男性中招募了 58 名男性。主要结局指标为 Alisklamp 的安全性以及参与者对其的效率和接受程度。
所有 58 例手术均无器械故障、出血或不理想的包皮切除。平均 ± SD 手术时间为 2.43 ± 1.36 分钟，平均器械移除时间为 15.8 ± 7.4 秒。有 2 例不良事件，包括轻度水肿和浅表伤口感染，各 1 例与卫生条件差有关。所有男性在割礼后立即恢复日常活动。58 名参与者中，25.9%出现轻度夜间勃起疼痛，无需用药。在 6 周的随访中，所有男性对手术过程均满意，对器械耐受良好，并会向朋友推荐。
Alisklamp 在使用该装置进行割礼的男性中具有极佳的安全性和可接受性。该技术易于教授，它将成为一种方便的设备，提高男性割礼的比例。基于这些发现，该设备值得进行临床对比研究。
