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临床试验/NCT06177834
NCT06177834已完成不适用

Comparison of Alisklamp and Dorsal Slit Sleeve Circumcision: A Randomized Controlled Trial

Mustafa Azizoğlu2 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
2
主要终点
infections

研究概览

简要总结

In this study the plan is to compare the circumcision performed with Alisklamp versus Dorsal Slit Sleeve method in terms of age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.

详细描述

The study compares two circumcision techniques in children: the dorsal sleeve slit method and the alisclamp method. The dorsal sleeve slit technique, conducted under local anesthesia for about 20-30 minutes, involves cutting the penile skin dorsally, removing excess skin and prepuce, and suturing with 5/0 vicryl. The alisclamp method, also under local anesthesia, entails retracting the penile skin, placing a clamp, excising excess prepuce, and sending the patient home. The clamp is removed after 48 hours without anesthesia, with the total procedure lasting under 5 minutes. This research assesses these methods based on factors like age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Minute 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • male patients between 0-2 years and 6-18 years

排除标准

  • 2-6 years, several penil chordee, hypospadias, previous penil surgery

结局指标

主要结局

infections

时间窗: 2 weeks

wound infections

wound dehiscence

时间窗: 2 weeks

wound dehiscence

Healing time

时间窗: 2 weeks

Healing time

skin tunnel

时间窗: 1 month

presense of the number of skin tunnel

次要结局

未报告次要终点

研究者

发起方
Mustafa Azizoğlu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mustafa Azizoğlu

MD

Necmi Kadıoğlu Hospital

研究点 (2)

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Alisklamp and Dorsal Slit Sleeve Circumcision | 临床试验