ClinicalTrials.gg
Not yet recruitingNCT06187844Updated Jan 3, 2024

Value of Inguinal Exploration for Impalpable Testes

An interventional study of Inguinal exploration and Laparoscopy in Undescended Testis and Inguinal; Testicle, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 6 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
6 Months to 12 Years
Sex
Male
01

Study 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 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:

  1. Blind-ending vessels, which indicate a vanishing intra-abdominal testis, and no further exploration is necessary (10%)
  2. 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.
  3. 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.
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Conditions studied

  • Undescended Testis
  • Inguinal; Testicle

Browse trials for

03

In context

Cryptorchidism

40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 26 interventional studies indexed under Cryptorchidism.

Browse Cryptorchidism studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 6m-12y
  • Impalpable tests (unilateral or bilateral)
  • Laparoscopy: cord structures entering the inguinal canal.

Exclusion criteria

Exclusion Criteria:

  • Patient refusing participation in the study.
  • Any 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Children with impalpable tests

    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.

    Procedure: Inguinal exploration · Procedure: Laparoscopy

Interventions

  • ProcedureInguinal exploration

    Inguinal exploration will be done for all the included patients.

  • ProcedureLaparoscopy

    All patients will have abdominal laparoscopy first to assess the location of the impalpable testis, the inguinal canal and the cord structures.

06

What researchers measure

Primary outcomes

  1. . 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.

    Time frame: 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. 1. History of inguinal or scrotal exploration 2. history of cryptorchidism 3. BMI (weight and height will be combined to report BMI in kg/m\^2) 4. size of the other testis in cm 5. scrotal compartment development 6. palpable scrotal nubbin

    Time frame: Preoperative

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Study locations

No study locations are listed for this record.

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References and documents

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 11752871 ↗
  • Fratric 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. Erratum In: Biomed Res Int. 2021 Jan 28;2021:6890257. doi: 10.1155/2021/6890257. PubMed 30112376 ↗
  • Van 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 11547102 ↗
  • Braga 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 25008806 ↗
  • Ueda 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 23480909 ↗
  • Rozanski TA, Wojno KJ, Bloom DA. The remnant orchiectomy. J Urol. 1996 Feb;155(2):712-3; discussion 714. PubMed 8558712 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2024; primary completion for Nov 2025, 21 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2023
First posted
Jan 3, 2024
StartEst.
Feb 1, 2024
Primary completionEst.
Nov 1, 2025
CompletionEst.
Dec 30, 2025
Last update
Jan 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06187844
Lead sponsor
Assiut University
Responsible party
Mohamed Omar Mohamed (Principal Investigator, Assiut University) — Principal investigator
First posted
Jan 3, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
Nov 1, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jan 3, 2024

Study contacts

Mohamed Omar, Resident
Contact
mohamed.oomar1996@gmail.com
+201010013292
Ahmed Abdel Hamed Metwaly, Ass. prof
Contact
aamshahat@gmail.com
+201003304611
Ahmed Abdel Hamed Metwaly, Ass. prof
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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