Clinical Trials Directory

Trials / Unknown

UnknownNCT03291678

Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Ahmed Hamdy Rateb · Academic / Other
Sex
Male
Age
6 Months – 2 Years
Healthy volunteers
Not accepted

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%

Conditions

Interventions

TypeNameDescription
PROCEDUREnew laparoscopic orchiopexyclosure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
PROCEDUREclassic laparoscopic orchiopexydelivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal

Timeline

Start date
2017-09-25
Primary completion
2018-09-05
Completion
2018-09-06
First posted
2017-09-25
Last updated
2017-09-26

Source: ClinicalTrials.gov record NCT03291678. Inclusion in this directory is not an endorsement.