Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device
研究概览
简要总结
The investigators are testing a novel surgical device to facilitate safe circumcision among adult males. The investigators hypothesize that this device will allow non-medical providers to perform safe surgical circumcision without adverse events.
详细描述
Objective
To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision.
Design: Prospective pilot trial of a novel surgical device Setting: Tertiary care Veterans Administration medical center Patients: 5 adult males Interventions: Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.
Main Outcome Measure(s): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Uncircumcised males
- •Sexually active
- •No plans for moving in next 6 months
- •Consent to participate
- •History of a bleeding disorder
- •History of a documented concurrent STI of appearance of an STI on initial physical exam
- •Keloid formation or other condition that might unduly increase risk of elective surgery
- •Asprin, anti-coagulants or other clinical contra-indications
排除标准
- 未提供
结局指标
主要结局
Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device
时间窗: 90 days
To determine if the novel surgical device was able to facilitate safe circumcision among adult males. Specifically we looked at: time of surgery, blood loss, ease of use, cosmetic outcome, number of sutures required, need for conversion to another method of circumcision and need for revision surgeries.
次要结局
- Time of circumcision(1 day)
研究者
John Krieger
Professor of Urology, University of Washington, Section chief Seattle VA urology division
VA Puget Sound Health Care System