Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- successful repair of the fistula
研究概览
简要总结
cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair
详细描述
Hypospadias is a common congenital urological birth defect. Urethro-cutaneous fistula (UCF) is the most common complication of surgical repair hypospadias and it remains the primary concern of surgeons dealing with hypospadias repair.
cyanoacrylate has been reported to enhance the healing process. this study tries to evaluate the clinical impact of cyanoacrylate on the repair of urethro-cutaneous fistula after surgical repair of hypospadias
this study evaluates the impact of using cyanoacrylate as an interposition substance in surgical repair of UCF after hypospadias in comparison to the classic surgical repair technique
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
- Single (Participant)
盲法说明
patients and their relatives were blinded to the type of the intervention
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with Urethro-cutaneous fistula regardless of their age were included in our study.
排除标准
- •Patients with fistula size more than 5 mm
- •multiple fistulas
- •uncorrected obstruction distal to the fistula
- •necrotic tissue
- •active infection at the fistula site
- •severely scarred skin
- •deficient dartos around the fistula
- •fistulas more proximal to the mid penile position
- •recurrent fistulas
- •previous history of hypersensitivity to cyanoacrylate-based products
研究组 & 干预措施
Cases of group (I) cyanoacrylate glue
Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.
干预措施: Cyanoacrylate, Isobutyl (Drug)
Cases of the control group (II) , classic repair
Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
干预措施: Classic surgical repair (Procedure)
结局指标
主要结局
successful repair of the fistula
时间窗: 6 months after surgery
surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present
次要结局
- postoperative complications(6 months after surgery)
研究者
Ahmed Maher Gamil Ahmed Higazy
assistant lecturer
Ain Shams University