Undescended TestisNCT06187844
Value of Inguinal Exploration for Impalpable Testes
A study testing Inguinal exploration and Laparoscopy in people with Undescended Testis and Inguinal; Testicle, run by Assiut University.
Trial summary
To determine the percentage of children with impalpable testis who benefit from inguinal exploration after laparoscopic identification of cord structures entering the inguinal canal. To determine the factors predicting the presence of inguinal testis in the previously mentioned children. Read more about this study
- Who is it for?
- Ages 6 months to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Undescended Testis, Inguinal; Testicle
- What is being tested?
- Inguinal exploration and Laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Dec 2025
- 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 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6m-12y
- Impalpable tests (unilateral or bilateral)
- Laparoscopy: cord structures entering the inguinal canal.
Who cannot join
- Patient refusing participation in the study.
- Any contraindication to laparoscopy
- laparoscopy: cord structures passing through an open inguinal canal through which the laparoscopy could be advanced and visualize the tests.
- Disorders of sexual differentiation.
- Children whose tests became palpable under anesthesia and those with a history of previous inguinal canal exploration (hydrocele or hernia repair) or orchidopexy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Value of Inguinal Exploration in Cases of Impalpable Testis With Cord Structures Entering the Inguinal Canal
- To determine the percentage of children with impalpable testis who benefit from inguinal exploration after laparoscopic identification of cord structures entering the inguinal canal.
- To determine the factors predicting the presence of inguinal testis in the previously mentioned children.
Read the detailed description
The undescended testis represents one of the most common disorders of childhood. The most useful classification of undescended testes is distinguishing palpable and non-palpable tests, and the location and presence of the tests decide clinical management. Approximately 80% of all undescended tests are palpable and the other 20% are impalpable. Among the 20% of non-palpable testes, 50-60% are intra-abdominal, canalicular, or peeping (right inside the internal inguinal ring). The remaining 20% are absent and 30% are atrophic or rudimentary.
Diagnostic laparoscopy is the most useful modality for assessing nonpalpable testicles. The four most important structures to identify at laparoscopy are the testis, the testicular vessels, the vase deferens, and the patency of the processus vaginalis. The possible anatomical findings include spermatic vessels entering the inguinal canal (40%), an intra-abdominal (40%) or peeping (10%) testis, or blind-ending spermatic vessels confirming vanishing testis (10%). It permits the identification of three surgical scenarios that will lead to different courses of action:
- Blind-ending vessels, which indicate a vanishing intra-abdominal testis, and no further exploration is necessary (10%)
- Testicular vessels and vas entering the inguinal canal through the internal inguinal ring (34%).Inguinal exploration may find a testicular nubbin either in the inguinal region or in the scrotum, which may or may not be removed; or a healthy, palpable, undescended testicle amenable to standard orchidopexy.
- Peeping (11%) or intra-abdominal tests (37%), which will require either an open or a laparoscopic approach. Although Rozanski et al. reported the first case of intratubular germ cell neoplasia originating from a testicular remnant, the necessity of removing nubbins is controversial.
- Conditions
- Undescended Testis, Inguinal; Testicle
- Being tested
- Inguinal exploration, Laparoscopy
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal explorationProcedure or surgery
Inguinal exploration will be done for all the included patients.
LaparoscopyProcedure or surgery
All patients will have abdominal laparoscopy first to assess the location of the impalpable testis, the inguinal canal and the cord structures.
| Study group | Role | What they receive |
|---|---|---|
| Children with impalpable tests | Experimental | For children with impalpable tests before and under anesthesia and by laparoscopy, cord structures could be seen entering the inguinal canal, inguinal exploration will be done. Receives: Procedure: Inguinal exploration; Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Percentage of positive inguinal exploration even by finding a testis or nubbin
To determine the percentage of children with impalpable testis who get benefit from inguinal exploration after laparoscopic identification of cord structures entering the inguinal canal.
Inguinal exploration may find a testicular nubbin either in the inguinal region or, most commonly, in the scrotum, which will be excised and sent for histopathology; or a healthy, palpable, undescended testicle amenable to standard orchidopexy.
Measured: Intraoperative
Secondary outcomes (1)
Association between these different factors and the presence of inguinal testis in whom impalpable by lap
We will investigate the following factors that may predict the presence of inguinal tests, thus supporting or avoiding inguinal exploration.
- History of inguinal or scrotal exploration
- history of cryptorchidism
- BMI (weight and height will be combined to report BMI in kg/m^2)
- size of the other testis in cm
- scrotal compartment development
- palpable scrotal nubbin
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Undescended TestisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omar Mohamed, Assiut University
- Investigators
- Ahmed Abdel Hamed Metwaly, Ass. prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187844
- Sponsor's protocol ID
- expl impalpable testes
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riedmiller H, Androulakakis P, Beurton D, Kocvara R, Gerharz E; European Association of Urology. EAU guidelines on paediatric urology. Eur Urol. 2001 Nov;40(5):589-99. doi: 10.1159/000049841. No abstract available.
PubMed 11752871Fratric I, Sarac D, Antic J, Dermanov M, Jokic R. Impalpable Testis: Evaluation of Diagnostic and Treatment Procedures and Our Treatment Protocol. Biomed Res Int. 2018 Jul 17;2018:3143412. doi: 10.1155/2018/3143412. eCollection 2018.
PubMed 30112376Van Savage JG. Avoidance of inguinal incision in laparoscopically confirmed vanishing testis syndrome. J Urol. 2001 Oct;166(4):1421-4. doi: 10.1097/00005392-200110000-00060.
PubMed 11547102Braga LH, Kim S, Farrokhyar F, Lorenzo AJ. Is there an optimal contralateral testicular cut-off size that predicts monorchism in boys with nonpalpable testicles? J Pediatr Urol. 2014 Aug;10(4):693-8. doi: 10.1016/j.jpurol.2014.05.011. Epub 2014 Jun 20.
PubMed 25008806Ueda N, Shiroyanagi Y, Suzuki H, Kim WJ, Yamazaki Y, Tanaka Y. The value of finding a closed internal ring on laparoscopy in unilateral nonpalpable testis. J Pediatr Surg. 2013 Mar;48(3):542-6. doi: 10.1016/j.jpedsurg.2012.09.032.
PubMed 23480909Rozanski TA, Wojno KJ, Bloom DA. The remnant orchiectomy. J Urol. 1996 Feb;155(2):712-3; discussion 714.
PubMed 8558712
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Inguinal Exploration in Cases of Impalpable Testis With Cord Structures Entering the Inguinal Canal
- ClinicalTrials.gov ID
- NCT06187844
- Acronym / sponsor ID
- expl impalpable testes
- Conditions
- Undescended Testis, Inguinal; Testicle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Jan 2024 (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.
- To determine the percentage of children with impalpable testis who benefit from inguinal exploration after laparoscopic identification of cord structures entering the inguinal canal.
- To determine the factors predicting the presence of inguinal testis in the previously mentioned children.
Detailed description
The undescended testis represents one of the most common disorders of childhood. The most useful classification of undescended testes is distinguishing palpable and non-palpable tests, and the location and presence of the tests decide clinical management. Approximately 80% of all undescended tests are palpable and the other 20% are impalpable. Among the 20% of non-palpable testes, 50-60% are intra-abdominal, canalicular, or peeping (right inside the internal inguinal ring). The remaining 20% are absent and 30% are atrophic or rudimentary.
Diagnostic laparoscopy is the most useful modality for assessing nonpalpable testicles. The four most important structures to identify at laparoscopy are the testis, the testicular vessels, the vase deferens, and the patency of the processus vaginalis. The possible anatomical findings include spermatic vessels entering the inguinal canal (40%), an intra-abdominal (40%) or peeping (10%) testis, or blind-ending spermatic vessels confirming vanishing testis (10%). It permits the identification of three surgical scenarios that will lead to different courses of action:
- Blind-ending vessels, which indicate a vanishing intra-abdominal testis, and no further exploration is necessary (10%)
- Testicular vessels and vas entering the inguinal canal through the internal inguinal ring (34%).Inguinal exploration may find a testicular nubbin either in the inguinal region or in the scrotum, which may or may not be removed; or a healthy, palpable, undescended testicle amenable to standard orchidopexy.
- Peeping (11%) or intra-abdominal tests (37%), which will require either an open or a laparoscopic approach. Although Rozanski et al. reported the first case of intratubular germ cell neoplasia originating from a testicular remnant, the necessity of removing nubbins is controversial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with impalpable tests | Experimental | Procedure: Inguinal exploration, Procedure: LaparoscopyFor children with impalpable tests before and under anesthesia and by laparoscopy, cord structures could be seen entering the inguinal canal, inguinal exploration will be done. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6m-12y
- Impalpable tests (unilateral or bilateral)
- Laparoscopy: cord structures entering the inguinal canal.
Key exclusion criteria (5 listed)
- Patient refusing participation in the study.
- Any contraindication to laparoscopy
- laparoscopy: cord structures passing through an open inguinal canal through which the laparoscopy could be advanced and visualize the tests.
- Disorders of sexual differentiation.
- Children whose tests became palpable under anesthesia and those with a history of previous inguinal canal exploration (hydrocele or hernia repair) or orchidopexy.
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 |
|---|---|---|
| Inguinal explorationInguinal exploration will be done for all the included patients. | Procedure or surgery | Children with impalpable tests |
| LaparoscopyAll patients will have abdominal laparoscopy first to assess the location of the impalpable testis, the inguinal canal and the cord structures. | Procedure or surgery | Children with impalpable tests |
Primary outcome
. Percentage of positive inguinal exploration even by finding a testis or nubbin
Time frame: Intraoperative
To determine the percentage of children with impalpable testis who get benefit from inguinal exploration after laparoscopic identification of cord structures entering the inguinal canal. Inguinal exploration may find a testicular nubbin either in the inguinal region or, most commonly, in the scrotum, which will be excised and sent for histopathology; or a healthy, palpable, undescended testicle amenable to standard orchidopexy.
1 secondary outcome
Association between these different factors and the presence of inguinal testis in whom impalpable by lap
Time frame: Preoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 11752871Riedmiller H, Androulakakis P, Beurton D, Kocvara R, Gerharz E; European Association of Urology. EAU guidelines on paediatric urology. Eur Urol. 2001 Nov;40(5):589-99. doi: 10.1159/000049841. No abstract available.
- Background: PubMed 30112376Fratric I, Sarac D, Antic J, Dermanov M, Jokic R. Impalpable Testis: Evaluation of Diagnostic and Treatment Procedures and Our Treatment Protocol. Biomed Res Int. 2018 Jul 17;2018:3143412. doi: 10.1155/2018/3143412. eCollection 2018.
- Background: PubMed 11547102Van Savage JG. Avoidance of inguinal incision in laparoscopically confirmed vanishing testis syndrome. J Urol. 2001 Oct;166(4):1421-4. doi: 10.1097/00005392-200110000-00060.
- Background: PubMed 25008806Braga LH, Kim S, Farrokhyar F, Lorenzo AJ. Is there an optimal contralateral testicular cut-off size that predicts monorchism in boys with nonpalpable testicles? J Pediatr Urol. 2014 Aug;10(4):693-8. doi: 10.1016/j.jpurol.2014.05.011. Epub 2014 Jun 20.
- Background: PubMed 23480909Ueda N, Shiroyanagi Y, Suzuki H, Kim WJ, Yamazaki Y, Tanaka Y. The value of finding a closed internal ring on laparoscopy in unilateral nonpalpable testis. J Pediatr Surg. 2013 Mar;48(3):542-6. doi: 10.1016/j.jpedsurg.2012.09.032.
- Background: PubMed 8558712Rozanski TA, Wojno KJ, Bloom DA. The remnant orchiectomy. J Urol. 1996 Feb;155(2):712-3; discussion 714.
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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.
Ahmed Abdel Hamed Metwaly, Ass. prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Inguinal exploration and Laparoscopy in people with Undescended Testis and Inguinal; Testicle, run by Assiut University.
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 5 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 3 Jan 2024. 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 Mohamed Omar, Resident (+201010013292, mohamed.oomar1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. Percentage of positive inguinal exploration even by finding a testis or nubbin (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187844, which also lists 6 linked publications.
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 3 Jan 2024.