Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy
NCT ID: NCT03291678
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-09-25
2018-09-06
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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new laparoscopic orchiopexy
this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring
new laparoscopic orchiopexy
closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
classic laparoscopic orchoipexy
this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum
classic laparoscopic orchiopexy
delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. SEX must be male
3. Surgical approach is closure of internal ring via percutaneous technique after delivery of undescended testis
Exclusion Criteria
2. Patients with palpable undescended testis
3. Any associated major congenital anomalies like cardiac anomalies
6 Months
2 Years
MALE
No
Sponsors
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Assiut University
OTHER
Ahmed Hamdy Rateb
OTHER
Responsible Party
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Ahmed Hamdy Rateb
resident physician of general surgery assuit university
Principal Investigators
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gamal abdel hamid ahmed, prof
Role: PRINCIPAL_INVESTIGATOR
prof of general surgery assuit university
Central Contacts
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Other Identifiers
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ASSUIT HOSPITAL UNIVERSITY
Identifier Type: -
Identifier Source: org_study_id