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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03291678
Enrollment
60
Registered
2017-09-25
Start date
2017-09-25
Completion date
2018-09-06
Last updated
2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Disorders

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%

Interventions

PROCEDUREnew laparoscopic orchiopexy

closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous

PROCEDUREclassic laparoscopic orchiopexy

delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal

Sponsors

Assiut University
CollaboratorOTHER
Ahmed Hamdy Rateb
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
MALE
Age
6 Months to 2 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
decrease incidence of congenital hernia which associated with undescended testisone yearpatient 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

Secondary

MeasureTime frameDescription
The secondary outcome measure postoperative complicationone week post operativeclose observation of the patient depending on follow up the wound daily ,occurence of edema by observation, good feeding of the patient by mother

Contacts

Primary ContactAhmed mohammed soliaman, dr
ahmed.ali15@med.au.edu.eg0201091672661
Backup Contactmohamed abdelkader osman, prof
osman@med.aun.edu.eg0201090266780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026