Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- decrease incidence of congenital hernia which associated with undescended testis
研究概览
简要总结
Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia
详细描述
Cryptorchidism is the most common genitourinary anomaly in male children. Its incidence can reach 3% in full term neonates, rising to 30% in premature boys . The treatment of the crypt orchid testicle is justified by the increased risk of infertility and malignancy, as well as an associated inguinal hernia and the risk of trauma to the ectopic testicle against the pubis. Furthermore, the psychological stigma of a missing testis for the patient, as well as the parents' anxiety is also factors that justify this type of treatment .
About 20% of crypt orchid testicles are non palpable. The treatment of non-descended testicles is mandatory due to the increased risk of infertility, present in up to 40% of the patients, as compared to 6% of control groups, including malignancy, which reaches 20 times that of normal adults .
The treatment of the crypt orchid testis before 2 years of age is recommended, treatment is necessary not only for the risk of malignancy, but also for the satisfaction and improvement in the quality of the patient's life and parents´ concern for their children's health.
In relation to diagnosis, despite a sensitivity of 70-90% in the diagnosis of inguinal testes, ultrasonography is not useful in intra-abdominal cases . Although presenting a better quality, both computed tomography and nuclear magnetic resonance lack sufficient sensitivity and specificity to be considered as gold standard diagnostic tools . More recently, the magnetic angioresonance was introduced with sensibility of 96% and specificity of 100%, but it is still a new method, with high costs, also requiring general anesthesia in children .
In relation to the treatment, the use of gonadotrophin for un descended testes presents a success rate of definitive descent to the scrotum of 21 to 56%, with better results in bilateral cases . Surgical treatment via an inguinal incision is the main treatment option for palpable testicles, but can also be employed for the evaluation and treatment of non-palpable testis. In this situation, however, surgical exploration can often require large incisions and extensive dissections, especially in bilateral cases. This can be avoided using laparoscopic evaluation, with a sensitivity and specificity reaching more than 90%
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
- 6 Months 至 2 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA
- •Age above six months
- •SEX must be male
- •Surgical approach is closure of internal ring via percutaneous technique after delivery of undescended testis
排除标准
- •Age less than 3 months
- •Patients with palpable undescended testis
- •Any associated major congenital anomalies like cardiac anomalies
研究组 & 干预措施
new laparoscopic orchiopexy
this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring
干预措施: new laparoscopic orchiopexy (Procedure)
classic laparoscopic orchoipexy
this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum
干预措施: classic laparoscopic orchiopexy (Procedure)
结局指标
主要结局
decrease incidence of congenital hernia which associated with undescended testis
时间窗: one year
patient follow up will be after 15 days and then after two months by examination of the operation site ,stitches , and hernial orifices to be sure of absence of congenital hernia
次要结局
- The secondary outcome measure postoperative complication(one week post operative)
研究者
Ahmed Hamdy Rateb
resident physician of general surgery assuit university
Assiut University