Value of Inguinal Exploration for Impalpable Testes

NCT06187844 | Unknown

• 1 other identifier: expl impalpable testes
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Undescended Testis; Inguinal; Testicle

Outcome Measures

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.

  Intraoperative

Secondary Outcomes (1)

• Association between these different factors and the presence of inguinal testis in whom impalpable by lap

  Preoperative

Study Arms (1)

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.

Procedure: Inguinal exploration; Procedure: Laparoscopy

Interventions

Inguinal exploration PROCEDURE

Inguinal exploration will be done for all the included patients.

Children with impalpable tests

Laparoscopy PROCEDURE

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

Children with impalpable tests

Eligibility Criteria

• Age: 6 Months - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 11752871 BACKGROUND

• 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.

  PMID: 30112376 BACKGROUND

• 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.

  PMID: 11547102 BACKGROUND

• 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.

  PMID: 25008806 BACKGROUND

• 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.

  PMID: 23480909 BACKGROUND

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

  PMID: 8558712 BACKGROUND

MeSH Terms

Conditions

Cryptorchidism

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ahmed Abdel Hamed Metwaly, Ass. prof

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Omar, Resident

CONTACT

+201010013292; mohamed.oomar1996@gmail.com

Ahmed Abdel Hamed Metwaly, Ass. prof

CONTACT

+201003304611; aamshahat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 30, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12