Use of 2-octylcyanoacrylate for Closure Urethrocutaneous Fistulas After Urethroplasty for Hypospadias
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Use of 2-octylcyanoacrylate for closure urethrocutaneous fistulas after urethroplasty for hypospadias.
研究概览
简要总结
Urethrocutaneous fistulae (UCF) represent one of the most frequent causes of morbidity after urethroplasty. Hypospadias can be repaired using different surgical techniques, but regardless of technique, the incidence of UCF ranges between 10% and 40%. The surgical repair of UCF remains the treatment of choice, even if some patients need further operations because of recurrences. The cyanoacrylates have been used as skin suture substitutes, and some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the management of UCF.
详细描述
Design Randomized clinical trial carried out in children with UCF that occurred after hypospadias repair. The patients will be assign to either the control or study groups.
The study group will include children with long-standing UCF that occurred at least 6 months after the initial intervention. After preparation of the fistula area, multiple layers of OCA will be apply, attaching the edges of the orifice. The same procedure will be repeated three times and the children will be follow for at least 6 months after treatment.
The control group will include children with long-standing UCF that occurred at least 6 months after the initial intervention. Patients will be scheduled for surgical treatment and will be follow for at least 6 months after surgery. If UCF recurred, a new intervention will be proposed.
The sample size was determined based on a prevalence of the complication (UCF) of 25% in the surgery group and 70% in the medically treated group, given a confidence level of 95% and a power of 0.20, which resulted in a minimum sample size of 18 patients per group.
The independent variables are the application of OCA in the UCF orifice or surgical treatment of UCF and the main outcome variable is FC without recurrence within at least 12 months follow-up. As confounding variables, we considered the children's age, the fistulous orifice diameter and the type of initial surgical procedure to which all were submitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children younger than 5 years old with at least one postoperative UCF with an external orifice less than 5 mm in diameter at the distal, proximal or medial penis,
- •Patients whose parents or guardians accepted inclusion in the study by signing the informed consent form
排除标准
- •Patients with an external orifice more than 5 mm in diameter
- •Iatrogenic or traumatic fistulae
- •The presence of obstruction distal to the fistula, necrotic tissue or active infection at the surgical site,
- •The presence of chronic diseases such as diabetes mellitus, renal or hepatic insufficiency, malignancy of any type or use of steroids and/or immunosuppressive therapy of any kind,
结局指标
主要结局
Use of 2-octylcyanoacrylate for closure urethrocutaneous fistulas after urethroplasty for hypospadias.
时间窗: 12 months after procedure.
Closure or recurrence of urethrocutaneous fistulas after cyanoacrylate application or surgical intervention.
次要结局
- Morbidity after applications(12 months after the procedure.)
研究者
GONZALEZ-OJEDA ALEJANDRO
PhD. MD
Instituto Mexicano del Seguro Social