Safety and Efficiency of Laparoscopic Management of Intra-canalicular (Emergent) Testis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Side of affected testis (number of cases)
研究概览
简要总结
Undescended testes (UDTs) are a relatively common finding in pediatrics with prevalence about 1-2% in newborns. Upon discovering a non-intrascrotal testis, it is important to determine whether the testis is palpable or non-palpable (1). A canalicular or 'emergent' testis may be impalpable initially and may be appear when it is 'milked' out of the inguinal canal (where it is concealed from detection) indicating that 15 to 40% of cryptorchidism are viable peeping/canalicular testis.
The laparoscopic approach for treating canalicular undescended testes offers many advantages over open inguinal orchiopexy. The laparoscopic technique maintains the integrity of the inguinal canal anatomy and eliminating the need to divide the epigastric vessels during dissection. The ability to dissect the testicular vessels at a higher extent would increase the vessel length available to lower the testis without strain.
- This is a prospective study will be conducted at Department of Pediatric Surgery, MCH hospital, Bisha, Saudia Arabia and Pediatric surgery Department , Al-Azhar University hospitals, Cairo, Egypt, from January 2019 to October 2020 to evaluate the safety and efficiency of laparoscopic orchiopexy of intracanalicular testis.
- Patients' age and laterality will be reported. Evaluation will be done for the operative difficulties, intraoperative complications, operative time and early postoperative complications.
Testicular site, size and vascularity will be evaluated by ultrasonography at 6th month post operatively. Also, cosmetic results will be evaluated by obtaining the parent's questioners at post-operative OPD clinic visits.
- Laparoscopic orchiopexy for management of inguinal canalicular undescended testes is a safe, effective, and less invasive, without disturbance of inguinal canal anatomy, with better cosmetic results.
详细描述
Aim of the study:
Herein, the study aims to evaluate the laparoscopic procedure for management of canalicular testis regarding operative safety, efficacy and post-operative outcomes.
Brief review of literature:
- Different management modalities for intra-canalicular (emergent) testes in male children (open surgery, Laparoscopy).
- Advantages of laparoscopic orchiopexy for intra-canalicular (emergent) testes.
Patients and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Months 至 48 Months(Child)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All children diagnosed as intra-canalicular (emergent/ peeping) testes
排除标准
- •Patients above 14 years of age,
- •with retractile testes,
- •with retractile testes that were distal to the external ring and
- •with nonpalpable testes
结局指标
主要结局
Side of affected testis (number of cases)
时间窗: 2 years
The side of the affected testis
Patients' age (in months)
时间窗: 2 years
Patients' age
Patients' weight (in kilograms)
时间窗: 2 years
Patients' weight
次要结局
- Operative time (in minutes)(1 day (day of surgery))
- Testicular site (in centimeters)(2 years)
- Testicular size (in cubic milliliters)(2 years)
- Parents' satisfaction (percent of each satisfaction grade)(2 years)
- Period of follow-up (in months)(2 years)
研究者
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine
Al-Azhar University
