Clinical trial NCT03291678: Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy
Official title: Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2017-09-25
Enrollment: 60
Sex: MALE
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group which is control group will not subjected to internal ring ligation and another group will subjected to closure of the internal ring
Primary purpose: TREATMENT

Brief summary: Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia

Detailed description: 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%

Eligibility criteria: * INCLUSION CRITERIA

  1. Age above six months
  2. SEX must be male
  3. Surgical approach is closure of internal ring via percutaneous technique after delivery of undescended testis
* EXCLUSION CRITERIA

  1. Age less than 3 months
  2. Patients with palpable undescended testis
  3. Any associated major congenital anomalies like cardiac anomalies

Primary outcomes:
measure: decrease incidence of congenital hernia which associated with undescended testis
timeFrame: one year
Secondary outcomes:
measure: The secondary outcome measure postoperative complication
timeFrame: one week post operative
Other outcomes:
Locations:
Study officials:
affiliation: prof of general surgery assuit university
name: gamal abdel hamid ahmed, prof
role: PRINCIPAL_INVESTIGATOR
References: