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No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya.

10-12岁男孩的No-flip ShangRing包皮环切术: 肯尼亚随机临床试验的结果。

  • 影响因子:3.02
  • DOI:10.1371/journal.pone.0233150
  • 作者列表:"Al Hussein Alawamlh O","Awori QD","Barone MA","Kim SJ","Goldstein M","Li PS","Lee RK
  • 发表时间:2020-05-22
Abstract

BACKGROUND:Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya. METHODS:We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately. RESULTS:All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes. CONCLUSION:No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa. TRIAL REGISTRATION:ClinicalTrials.gov registration # NCT02390310.

摘要

背景: 最近人们的注意力转向使用器械辅助男性包皮环切术,以帮助扩大撒哈拉以南非洲的男性包皮环切服务,越来越重视年轻群体。我们评估了在肯尼亚参加两项随机临床试验的10至12岁男孩亚组中使用尚宁进行包皮环切术的情况。 方法: 我们对197名年龄在10 ~ 12岁的男孩进行了结果的子分析; 一个子集参加了两项随机临床试验,以评估在男性和男孩中使用无翻盖尚格林包皮环切术。一项试验评估了包皮环切术后7天的shangrying的自发脱离与计划移除。第二项试验比较了局部麻醉与注射麻醉与尚格林包皮环切术的使用。除了基线特征外,还分别收集和分析每个试验的数据。 结果: 所有受试者均成功行包皮环切术。在每个试验中,两组之间的包皮环切术持续时间、需要背侧切口的参与者、不良事件发生率、伤口完全愈合时间和参与者满意度相似.自发性上饶市脱离所需的平均时间为14.82 ± 3.76天。表面麻醉在施用时 (0.64 ± 1.71 vs. 1.55 ± 2.21,p = 0.03) 以及术后 (0.54 ± 0.88 vs. 1.72 ± 1.56,p<0.0001) 显示出显著较低的平均疼痛评分。局部麻醉剂的中位停留时间为43 (IQR: 35.5-60) 分钟,而注射麻醉剂起效的中位时间为2.04 (IQR: 1.72-3.09) 分钟。 结论: No-flip ShangRing包皮环切术在青少年男孩中具有积极的安全性,特别是年龄在10-12岁之间。在该年龄组中,自发装置脱离和表面麻醉的使用显示出有希望的结果。这可能有可能进一步提高ShangRing包皮环切术的可接受性,从而加速撒哈拉以南非洲男性包皮环切术服务的升级。 试验注册: clinicaltrials.Gov注册号 # nct02390310。

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