Value of Inguinal Exploration for Impalpable Testes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Undescended Testis; Inguinal; Testicle
• Intervention / Treatment: Procedure: Inguinal exploration; Procedure: Laparoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Omar, Resident; Phone Number: +201010013292; Email: mohamed.oomar1996@gmail.com
• Study Contact Backup: Name: Ahmed Abdel Hamed Metwaly, Ass. prof; Phone Number: +201003304611; Email: aamshahat@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Inguinal exploration will be done for all the included patients.; Procedure: Laparoscopy; All patients will have abdominal laparoscopy first to assess the location of the impalpable testis, the inguinal canal and the cord structures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. 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.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Preoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Abdel Hamed Metwaly, Ass. prof, Assiut University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Testicular Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Cryptorchidism
• Other Study ID Numbers: expl impalpable testes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No