INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA

May 12, 2026 updated by: Mehmet Said Koprulu, Trakya University

Investigation of the Genetic Etiology of Hernia Sac Development in Male Children With Undescended Testis and Inguinal Hernia

The aim of the project is to elucidate the genetic etiology underlying the development of the processus vaginalis (PV) in male children with indirect inguinal hernia (IIH) and undescended testis (UT), through the investigation of potential variants in the INSL3, WT1, and GATA6 genes using next-generation sequencing (NGS), and to explore possible differences in the tissue-level expression of these genes by real-time PCR analysis.

Indirect inguinal hernia represents a significant clinical problem for human health, due to its high prevalence in the population and its potential to cause life-threatening conditions or permanent functional loss. The treatment of both of these conditions, under current circumstances, requires surgical intervention. In the course of IIH, segmental loss of reproductive organs and intestines in both girls and boys, together with ischemia-reperfusion injury occurring in these tissues, constitute serious medical complications that cannot be overlooked. Furthermore, the substantial economic cost associated with the management of such severe complications necessitates meticulous control of the process. UT, on the other hand, is being observed with increasing frequency today and represents a significant health problem in society, as it is closely associated with reproductive disorders.

Clarifying the mechanisms underlying the pathogenesis of both inguinal region diseases will make a critical contribution not only to protecting individual health, but also to advancing societal well-being and scientific knowledge. Moreover, the data obtained from this study are expected to provide new perspectives for IIH and UT treatment approaches and form a scientific basis for future studies in the field.

This prospective cross-sectional study will comprise 20 patients with indirect inguinal hernia, 20 patients with undescended testis, and 20 patients undergoing circumcision, consecutively admitted to the Department of Pediatric Surgery, Faculty of Medicine, Trakya University. Patent processus vaginalis tissues excised during surgery from patients with IIH and UT, and preputial tissues obtained from patients in the circumcision group, will be collected. Tissue and blood samples taken from the patients will be transferred to the Department of Medical Genetics, Faculty of Medicine, Trakya University, for further analyses.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22020
        • Trakya University Faculty of Medicine, Department of Pediatric Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who present to the Pediatric Surgery Outpatient Clinic of Trakya University Faculty of Medicine between September 2025 and September 2026, including 20 diagnosed with IIH, 20 diagnosed with IT, and 20 presenting for circumcision, and for whom informed consent has been obtained, will be consecutively enrolled in the study.

Description

Inclusion Criteria:

  • All pediatric age groups
  • Patients with Indirect Inguinal Hernia without additional systemic or inguinoscrotal diseases
  • Patients with Undescended Testis without additional systemic or inguinoscrotal diseases
  • Patients requesting circumcision without additional systemic or inguinoscrotal diseases
  • Healthy children undergoing circumcision for traditional reasons

Exclusion Criteria:

  • Patients with recurrence, hydrocele, prior abdominal/inguinoscrotal surgery, genetic disorders, or incarcerated/strangulated IIH
  • Any syndromic disease
  • Bilateral IIH patients
  • Bilateral UT patients
  • Patients with hypospadias, micropenis, disorders of sex development, or genitourinary anomalies/diseases
  • Presence of umbilical, femoral, Spigelian, or lumbar hernia
  • History of premature birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Genetic Variants in INSL3, WT1, and GATA6 Genes
Time Frame: Up to 3 months after completion of the study
Investigation of potential genetic variants and mutations in INSL3, WT1, and GATA6 genes using Next-Generation Sequencing (NGS) from both processus vaginalis (PV) tissues and genomic DNA obtained from leukocytes.
Up to 3 months after completion of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of Gene Expression Levels in Processus Vaginalis Tissues
Time Frame: Up to 3 months after completion of the study
Evaluation of the mRNA expression levels of INSL3, WT1, and GATA6 genes in PV tissues using Real-Time PCR to determine tissue-specific differences in gene regulation.
Up to 3 months after completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2025

Primary Completion (Actual)

April 10, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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