Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy

Congenital Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03291678
• Other study ID #: ASSUIT HOSPITAL UNIVERSITY
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2017
• Last updated: September 24, 2017
• Start date: September 25, 2017
• Est. completion date: September 6, 2018

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Ahmed mohammed soliaman, dr
• Phone: 0201091672661
• Email: ahmed.ali15[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 6, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 2 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Congenital Disorders

Intervention

Procedure:
• new laparoscopic orchiopexy
closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
• classic laparoscopic orchiopexy
delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed Hamdy Rateb	Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Secondary	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	one week post operative