Value of Inguinal Exploration for Impalpable Testes

NCT ID: NCT06187844

Last Updated: 2024-01-03

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-30

Brief Summary

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* 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

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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.

Conditions

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Undescended Testis Inguinal; Testicle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Inguinal exploration

Intervention Type PROCEDURE

Inguinal exploration will be done for all the included patients.

Laparoscopy

Intervention Type PROCEDURE

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

Interventions

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Inguinal exploration

Inguinal exploration will be done for all the included patients.

Intervention Type PROCEDURE

Laparoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Omar Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Abdel Hamed Metwaly, Ass. prof

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Mohamed Omar, Resident

Role: CONTACT

+201010013292

Ahmed Abdel Hamed Metwaly, Ass. prof

Role: CONTACT

+201003304611

References

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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.

Reference Type BACKGROUND
PMID: 11752871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30112376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11547102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25008806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23480909 (View on PubMed)

Rozanski TA, Wojno KJ, Bloom DA. The remnant orchiectomy. J Urol. 1996 Feb;155(2):712-3; discussion 714.

Reference Type BACKGROUND
PMID: 8558712 (View on PubMed)

Other Identifiers

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expl impalpable testes

Identifier Type: -

Identifier Source: org_study_id

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