Clinical trial NCT06187844: Value of Inguinal Exploration for Impalpable Testes
Official title: Value of Inguinal Exploration in Cases of Impalpable Testis With Cord Structures Entering the Inguinal Canal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Undescended Testis
Inguinal; Testicle
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 50
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: . Percentage of positive inguinal exploration even by finding a testis or nubbin
timeFrame: Intraoperative
Secondary outcomes:
measure: Association between these different factors and the presence of inguinal testis in whom impalpable by lap
timeFrame: Preoperative
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed Abdel Hamed Metwaly, Ass. prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Rozanski TA, Wojno KJ, Bloom DA. The remnant orchiectomy. J Urol. 1996 Feb;155(2):712-3; discussion 714.