Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To evaluate the volume of the operated testis via ultrasound measurements.
研究概览
简要总结
This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).
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
- None
入排标准
- 年龄范围
- 4 Months 至 36 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys age 4 months to 36 months
- •Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens Orchiopexy would be appropriate.
排除标准
- •Age > 36 months
- •Age < 4 months
- •Bilateral cryptorchidism
- •Solitary testis
- •Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated
- •Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels.
- •Assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.
研究组 & 干预措施
Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
Stage 2 2 surgeries: 1st surgery-Clip vessels to testis. 2nd surgery done 6-12 months later, divide the spermatic vessels and bring the testis into the scrotum.
干预措施: Two-stage Fowler-Stephens orchidopexy (FSO) (Procedure)
Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
干预措施: Single-stage Fowler-Stephens orchidopexy (FSO) (Procedure)
结局指标
主要结局
To evaluate the volume of the operated testis via ultrasound measurements.
时间窗: 6-12 months after final FSO surgery
To evaluate the volume of the operated testis at 6-12 months after single-stage Fowler-Stephens orchidopexy (FSO) (6-12 months after two- stage FSO), as determined by ultrasound measurements. This will be compared to the intra-operative testicular measurements done during the laparoscopy.
次要结局
未报告次要终点
研究者
Caleb Nelson
Caleb Nelson, MD MPH
Boston Children's Hospital