Congenital DisordersNCT03291678
Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy
A study testing new laparoscopic orchiopexy and classic laparoscopic orchiopexy in people with Congenital Disorders, run by Ahmed Hamdy Rateb.
Trial summary
Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia Read more about this study
- Who is it for?
- Ages 6 months to 2 years, men only
- Conditions the study is for
- Congenital Disorders
- What is being tested?
- new laparoscopic orchiopexy and classic laparoscopic orchiopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2017to 6 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Age above six months
- SEX must be male
- Surgical approach is closure of internal ring via percutaneous technique after delivery of undescended testis
Who cannot join
- Age less than 3 months
- Patients with palpable undescended testis
- Any associated major congenital anomalies like cardiac anomalies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique
Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing incidence of congenital hernia
Read the 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
- Congenital Disorders
- Being tested
- new laparoscopic orchiopexy, classic laparoscopic orchiopexy
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new laparoscopic orchiopexyProcedure or surgery
closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
classic laparoscopic orchiopexyProcedure or surgery
delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal
| Study group | Role | What they receive |
|---|---|---|
| new laparoscopic orchiopexy | Experimental | this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring Receives: Procedure: new laparoscopic orchiopexy |
| classic laparoscopic orchoipexy | Active comparator | this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum Receives: Procedure: classic laparoscopic orchiopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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
Measured: one week post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start25 Sep 2017 (estimated)
- Primary completion5 Sep 2018 (estimated)
- Study completion6 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Hamdy Rateb
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Ahmed Hamdy Rateb, Assiut University
- Investigators
- gamal abdel hamid ahmed, prof, Principal investigator, prof of general surgery assuit university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291678
- Sponsor's protocol ID
- ASSUIT HOSPITAL UNIVERSITY
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique
- ClinicalTrials.gov ID
- NCT03291678
- Acronym / sponsor ID
- ASSUIT HOSPITAL UNIVERSITY
- Conditions
- Congenital Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed Hamdy RatebUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 25 Sep 2017 (estimated)
- Primary completion
- 5 Sep 2018 (estimated)
- Study completion
- 6 Sep 2018 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| new laparoscopic orchiopexy | Experimental | Procedure: new laparoscopic orchiopexythis group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring |
| classic laparoscopic orchoipexy | Active comparator | Procedure: classic laparoscopic orchiopexythis group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new laparoscopic orchiopexyclosure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous | Procedure or surgery | new laparoscopic orchiopexy |
| classic laparoscopic orchiopexydelivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal | Procedure or surgery | classic laparoscopic orchoipexy |
Primary outcome
decrease incidence of congenital hernia which associated with undescended testis
Time frame: one year
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
1 secondary outcome
The secondary outcome measure postoperative complication
Time frame: one week post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gamal abdel hamid ahmed, prof principal investigator
prof of general surgery assuit university
Questions about this trial
What is this clinical trial studying?
A study testing new laparoscopic orchiopexy and classic laparoscopic orchiopexy in people with Congenital Disorders, run by Ahmed Hamdy Rateb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed mohammed soliaman, dr (0201091672661, ahmed.ali15@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease incidence of congenital hernia which associated with undescended testis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.