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临床试验/NCT07319637
NCT07319637已完成不适用

Comparison of the Outcome of Orchidopexy With and Without Sac Ligation in Paediatric Population With Palpable Undescended Testis

Children Hospital Faisalabad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Operative Time

研究概览

简要总结

When a child has an undescended testicle that can be felt in the groin, surgery (orchiopexy) is needed to move it into the scrotum. During this operation, doctors sometimes tie off a small sac near the testicle, but this step can make the surgery longer and may slightly increase risks like swelling, infection, or irritation.

This study looks at whether tying this sac is really necessary. It compares children who had surgery with sac ligation to those who had surgery without it. The goal is to see if there is any difference in surgery time or the chance of developing a hernia afterward. By understanding this, doctors can choose the safest and simplest approach for children with undescended testicles and provide better care.

详细描述

Cryptorchidism or Undescended testis (UDT) is described as testes that cannot be brought down to the bottom of scrotum without undue traction on the spermatic cord. It is one of the most common conditions presenting in pediatric surgical outpatient department1. UDT is seen in 2-4% of children at birth, decreasing to about 1% in the first year of life. It is prevalent in about one to four and a half percentage of newborns with a higher incidence in preterm babies (30-45%). UDT maybe unilateral or bilateral, mostly affecting the right side (70%).

The management of palpable undescended testes (UDT) in the pediatric population often necessitates surgical intervention to relocate the testes into the scrotum, a procedure known as orchiopexy. During this surgery, surgeons may choose to either ligate the hernia sac associated with the undescended testis or leave it unligated. The decision to ligate the sac is influenced by the belief that it might reduce the risk of post-operative complications such as inguinal hernias. However, this additional step could potentially prolong the operative time and introduce other risks.

Studies suggest there is probability of spontaneous decent in the first three months postnatally, beyond which it was rare. The recommended age for surgery for undescended testis is six months of age. The standard surgical intervention for orchiopexy was described in 1881-1899. The classical orchidopexy recommends the mandatory ligation of the hernial sac to prevent occurrence of postoperative hernia. This traditional conventional orchidopexy technique is well-acknowledged and generally practiced and is well supported by many studies that conclude that sac ligation is mandatory for the prevention of post-operative complication of inguinal hernia5. However, recent evidence advocates that orchidopexy with ligation of hernial sac is unnecessary procedure with increased occurrence of severe pain post-operatively along with increased chances of testicular atrophy due to inadvertent injury to the adjacent structures6. Furthermore, it has been found that orchidopexies without ligation of sac technique is simple, save intraoperative time and equally effective with comparable outcomes.

A recent study on orchidopexy with and without sac ligation in pediatric patients was conducted to compare mean operative time and incidence of complications including post-operative hernia A total of hundred patients were recruited in this study. In one group orchidopexy without dissection and ligation of peritoneal sac was done, while in other group included the patients in which sac ligation was performed. In this study 60 (60%) patients had left-sided whereas 40 (40%) patients had right-sided UDT. The mean operative time of the patients from no sac ligation group was 21.25±0.90 minutes whereas in ligation group 33.10±1.10 minutes. Interestingly, no case of post-operative hernia was noted in both groups (0.00%).

Rationales of the study: The surgical management of palpable undescended testes (UDT) in children involves the critical decision of whether to ligate the associated hernia sac, a step that may prolong operative time and introduce additional risks such as inflammation, infection, or tissue damage. This study aims to evaluate the impact of sac ligation on operative time and the incidence of post-operative inguinal hernias, providing a comprehensive risk-benefit analysis. By comparing the outcomes of pediatric orchiopexy with and without sac ligation, the study seeks to generate high-quality evidence to guide surgical practice, standardize care, and ultimately improve patient outcomes and healthcare resource utilization in the treatment of palpable UDT.

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 15 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male children ≤15 years with palpable UDT
  • Scheduled for single stage orchidopexy

排除标准

  • Impalpable testes
  • Staged/laparoscopic procedures,
  • Pre-op hernia,
  • History previous orchiopexy
  • Ambiguous genitalia

研究组 & 干预措施

Group A

Active Comparator

Orchiopexy with sac ligation

干预措施: Orchiopexy with sac ligation (Procedure)

Group B

Experimental

Orchiopexy without sac ligation

干预措施: Orchiopexy without sac ligation (Procedure)

结局指标

主要结局

Operative Time

时间窗: During surgery "from skin incision to skin closure", assessed at the time of the surgical procedure.

Post-operative Complications

时间窗: at 0, 4, 8 and 12 weeks after surgery

Post-op hernia, Wound infection, Hematoma and Testicular atrophy

次要结局

  • Hospital stay duration, or Length of Stay (LOS) in the hospital(From the day of the admission for procedure until hospital discharge, assessed during the index hospitalization (up to 7 days))
  • Post-operative Pain Score(Post-operative period, assessed at 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.)

研究者

发起方
Children Hospital Faisalabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rida Dawood

Postgraduate Resident

Children Hospital Faisalabad

研究点 (1)

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