Circumcision Versus Preputioplasty for BXO in Children: A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Protocol Adherence
研究概览
简要总结
Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this approach has long been held as the 'gold standard. Whilst this may be curative in many cases, it has been shown that 20% of boys require a further operative procedure on their penis to widen the urethral opening (to treat meatal stenosis)
An alternative to circumcision was proposed: a preputioplasty (surgery to widen the opening of the foreskin) was combined with injection of steroids into the affected foreskin. Subsequently, the same group compared the outcomes of this technique with circumcision, and reported circumcision was successfully avoided in 92% of the preputioplasty group. In addition, the rate of meatal stenosis (narrowing of the urethral opening requiring surgery) was significantly lower (6% vs 19%, P = .034 ). Preputioplasty may therefore: (i) offer protection against meatal stenosis and reduce the requirement for further surgery; and (ii) offer the benefit of retaining the foreskin, the function of which, while debated, likely includes sexual function. In view of these potential benefits, authors have called for a randomised trial to compare circumcision to preputioplasty and injection of steroids.
详细描述
The interventions to be compared are operations to treat BXO called:
(i) circumcision: this will be a standard surgical circumcision whereby the prepuce (foreskin of the penis) is excised and the cut edge of the outer prepuce sutured to the cut edge of the inner prepuce. The two study team members performing the surgery in this trial (HC and SK) will be free to choose the method of circumcision (e.g. guillotine vs. sleeve) as this is not thought to influence outcome. The foreskin will be sent for histological analysis.
(ii) preputioplasty with intralesional injection of triamcinolone. Briefly, longitudinal incisions will be placed in the area of phimosis, and these will be sutured transversely to allow the prepuce to become retractile. A biopsy of an area of affected foreskin will be sent for histological analysis. The intention will be to perform three incisions (tri-radiate) but the final decision on how many will be made by the operating surgeon and based on the appearance of the prepuce and result of initial incision(s). Once the prepuce is felt to be freely retractile, 1 - 3 mL of triamcinolone (Adcortyl Bristol-Myers Squibb 10 mg/mL) will be injected intradermally around the circumference of the affected foreskin using a 25-gauge needle.
These procedures are established treatments for BXO and currently in use by the trial surgeons in the same setting as the trial.The preputioplasty with injection of triamcinolone procedure has previously been approved by the Alder Hey Children's Hospital NHS Trust Clinical Development Evaluation Group (CDEG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 2 and 16 years
- •diagnosed with BXO
- •require surgery to treat BXO
排除标准
- •previous penile surgery
- •circumcision or preputioplasty medically contraindicated
研究组 & 干预措施
circumcision
(i) circumcision: this will be a standard surgical circumcision whereby the prepuce (foreskin of the penis) is excised and the cut edge of the outer prepuce sutured to the cut edge of the inner prepuce.
干预措施: circumcision (Procedure)
preputioplasty with intralesional injection of triamcinolone
(ii) preputioplasty with intralesional injection of triamcinolone: longitudinal incisions will be placed in the area of phimosis, and these will be sutured transversely to allow the prepuce to become retractile.
干预措施: preputioplasty with intralesional injection of triamcinolone: (Procedure)
结局指标
主要结局
Protocol Adherence
时间窗: 12 months
Rate of adherence to protocol-data collected by study team
Recruitment Rate
时间窗: 12 months
Recruitment Rate including reasons for non-recruitment.
Drop Out
时间窗: 12 months
Rate of drop-out from the study
次要结局
- Clinical outcomes-Return to theatre(30 days)
- Clinical outcomes-patient satisfaction(3 months & 1 year)
- Clinical outcomes-functional outcomes(6 weeks, 3 months & 1 year)
- Patient Satisfaction(6 weeks, 3 months and 12 months)
- Clinical outcomes-Readmissions to hospital(30 days)
- Clinical outcomes-Subsequent penile surgery(1 year)
- Clinical outcomes-Surgical complications(72 hours)