跳至主要内容
临床试验/NCT06558994
NCT06558994招募中不适用

Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis. Randomized Study

Assiut University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
58
试验地点
1
主要终点
testis-to-ring distance in mm at the second stage

研究概览

简要总结

This is a comparative study to see the outcome of yransection versus ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis in assisting the descent of the testis to the base of scrotum during the second stage

详细描述

Cryptorchidism is one of the most commin congenital deformities of male newborns, known as undescended testis (UDT). The incidence ranges according to gestational age, affecting 1.0-4.6% of full-term infants and 1.1-45% of preterm infants. (UDT) is a condition in which the testicles are not found at the base of the scrotum. Studies have shown that the undescended testicle has a potential of spontaneous descent during the first 3 months of life and is less likely to do so after 6 months of age. In almost 20% of cases the undescended testes are not palpable, increasing the difficulty of investigations and treatment, and 30% of these cases are also intra-abdominal. If UDT left untreated, it can cause histological alterations of the testicular cells and increasing of the risks of infertility.

As of treatment of UDT, laparoscopic surgery is ,for most surgeons, the preferred technique. Several techniques have been described for laparoscopic orchidopexy. After spermatic vascular transection, single-stage testicular descent fixing was carried out, as Fowler and Stephens (FSO) first described in 1959. Since 1996, a two-stage laparoscopic Fowler-Stephens technique involving preservation of the gubernacular vessels and performing an entirely laparoscopic second stage. The second stage is presently performed 6-9 months after the first.

Recently, laparoscopic FSO has been adopted to treat high-level IATs, for its minimally invasive wound and acceptable success rate.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • All patients with Unilateral or Bilateral impalpable testis

排除标准

  • Previous Laparotomy surgery
  • Previous Ventriculo-peritoneal shunt
  • Previous laparoscopy for impalpable testis (outside study)
  • Previous Inguinal/Scrotal surgery
  • Disorder of sexual differentiation
  • Abnormal Karyotyping
  • Intra-operative Inguinal testis
  • Ipsilateral testis : Peeping/ Vas internal internal ring / Vanished / Streak / Ovotestis / Ovary.
  • Contralateral : Streak/ Ovotestis/ Ovary

研究组 & 干预措施

Transection arm

Active Comparator

Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis

干预措施: Transection of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis (Procedure)

Ligation arm

Active Comparator

ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis

干预措施: Ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis (Procedure)

结局指标

主要结局

testis-to-ring distance in mm at the second stage

时间窗: At 6 months after the first stage (during the second stage)

After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the location of the testis away from the internal inguinal ring (the testis-to-ring distance in mm) will be measured during the 2nd stage (degree of descent) 6 months after the first stage and compared among the two groups.

Testicular volume in mL

时间窗: At 6 months after the first stage (during the second stage)

After either of transection or ligation of the spermatic vessels during the first stage of laparoscopic Fowler-Stephens orchidopexy, the testicular volume in mL will be assessed intraoperatively during the second stage (6 months after the first stage) and compared among the two groups.

次要结局

  • Operative time in minutes(At 6 months after the first stage (during the second stage))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Mohamed Atef Abdelaziz Mostafa

Lecturer of Urology

Assiut University

研究点 (1)

Loading locations...

相似试验