An interventional study of new laparoscopic orchiopexy and classic laparoscopic orchiopexy in Congenital Disorders, sponsored by Ahmed Hamdy Rateb. Status unknown. Open to male participants aged 6 Months to 2 Years. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Ahmed Hamdy Rateb · Not applicable, Interventional, and Treatment
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Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia
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%
110 studies on the registry are indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 20 are open to participants now.
This study's planned enrollment of 60 is above the median of 41 across 30 interventional studies indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities.
Browse Congenital, Hereditary, and Neonatal Diseases and Abnormalities studies →This is the only study on the registry with Ahmed Hamdy Rateb as lead sponsor.
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Age above six months
Age less than 3 months
this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring
Procedure: new laparoscopic orchiopexy
this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum
Procedure: classic laparoscopic orchiopexy
closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal
decrease incidence of congenital hernia which associated with undescended testis
patient follow up will be after 15 days and then after two months by examination of the operation site ,stitches , and hernial orifices to be sure of absence of congenital hernia
Time frame: one year
The secondary outcome measure postoperative complication
close observation of the patient depending on follow up the wound daily ,occurence of edema by observation, good feeding of the patient by mother
Time frame: one week post operative
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2017; primary completion for Sep 2018, 11 months later.
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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Congenital, Hereditary, and Neonatal Diseases and Abnormalities →