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使用局部麻醉的无缝合成人自愿男性包皮环切术:一次性手术器械Unicirc的随机现场试验。

Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument.

作者信息

Shenje Justin, Millard Peter S

机构信息

Department of Epidemiology, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.

Department of Epidemiology, Graduate Program in Public Health, University of New England, Portland, Maine, United States of America.

出版信息

PLoS One. 2016 Jun 14;11(6):e0157065. doi: 10.1371/journal.pone.0157065. eCollection 2016.

DOI:10.1371/journal.pone.0157065
PMID:27299735
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4907451/
Abstract

INTRODUCTION

The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC).

STUDY DESIGN

Non-blinded randomized controlled field trial with 2:1 allocation ratio.

PARTICIPANTS

75 adult male volunteers.

SETTING

Outpatient primary care clinic.

INTERVENTION

Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive.

PRIMARY OUTCOME

Intraoperative duration.

SECONDARY OUTCOMES

Intraoperative and postoperative pain; adverse events; time to healing; patient satisfaction; cosmetic result.

RESULTS

The intraoperative time was less with the Unicirc technique (median 12 vs. 25 min, p < 0.001). Wound healing and cosmetic results were superior in the Unicirc group. Adverse events were similar in both groups.

CONCLUSIONS

VMMC with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is rapid, heals by primary intention with superior cosmetic results, and is potentially safer and more cost-effective than open surgical VMMC.

TRIAL REGISTRATION

Clinicaltrials.gov NCT02443792.

摘要

引言

世界卫生组织已寻求快速且微创的技术,以促进扩大自愿男性包皮环切术(VMMC)的规模。

研究设计

非盲法随机对照现场试验,分配比例为2:1。

参与者

75名成年男性志愿者。

地点

门诊基层医疗诊所。

干预措施

局部麻醉下开放手术包皮环切术并缝合与使用Unicirc一次性器械在表面麻醉下进行手术并用氰基丙烯酸酯组织粘合剂封闭伤口。

主要结局

手术时长。

次要结局

术中及术后疼痛;不良事件;愈合时间;患者满意度;美观效果。

结果

使用Unicirc技术的手术时间更短(中位数分别为12分钟和25分钟,p<0.001)。Unicirc组的伤口愈合和美观效果更佳。两组的不良事件相似。

结论

在表面麻醉下使用Unicirc进行VMMC并用氰基丙烯酸酯组织粘合剂封闭伤口,手术快速,一期愈合且美观效果更佳,与开放手术VMMC相比可能更安全且更具成本效益。

试验注册

Clinicaltrials.gov NCT02443792。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba8c/4907451/7ef1bb88550d/pone.0157065.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba8c/4907451/7ef1bb88550d/pone.0157065.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba8c/4907451/7ef1bb88550d/pone.0157065.g001.jpg

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本文引用的文献

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MMWR Morb Mortal Wkly Rep. 2016 Jan 22;65(2):36-7. doi: 10.15585/mmwr.mm6502a5.
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PrePex Male Circumcision: Follow-Up and Outcomes during the First Two Years of Implementation at the Rwanda Military Hospital.PrePex男性包皮环切术:卢旺达军事医院实施头两年的随访与结果
PLoS One. 2015 Sep 23;10(9):e0138287. doi: 10.1371/journal.pone.0138287. eCollection 2015.
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HIV shedding from male circumcision wounds in HIV-infected men: a prospective cohort study.
环切器械与标准手术技术在青少年和成年男性包皮环切术中的比较:一项 Cochrane 综述。
BJU Int. 2022 Jul;130(1):26-34. doi: 10.1111/bju.15604. Epub 2021 Oct 18.
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Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.环切器械与标准手术技术在青少年和成年男性割礼中的比较。
Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.
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Transl Androl Urol. 2020 Apr;9(2):516-522. doi: 10.21037/tau.2019.12.16.
HIV感染男性包皮环切伤口的HIV脱落情况:一项前瞻性队列研究。
PLoS Med. 2015 Apr 28;12(4):e1001820. doi: 10.1371/journal.pmed.1001820. eCollection 2015 Apr.
4
Sutureless circumcision using 2-Octyl cyanoacrylate results in more rapid and less painful procedures with excellent cosmetic satisfaction.使用2-氰基丙烯酸辛酯进行无缝合包皮环切术可使手术过程更快速、疼痛更少,且美容效果令人满意。
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