Indirect Inguinal HerniaNCT07586332
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
An observational study of Indirect Inguinal Hernia and Undescended Testis, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Indirect Inguinal Hernia, Undescended Testis
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2025to 1 Mar 2027
- How long will I take part?
- 14 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Faculty of Medicine, Department of Pediatric Surgery
Edirne, 22020
About this study
Official title: 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.
Read more
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.
- Conditions
- Indirect Inguinal Hernia, Undescended Testis
- Keywords
- children, inguinal hernia, undescended testis, processus vaginalis, gata6, wt1, insl3
- Medical subject headings
- Hernia, Inguinal, Cryptorchidism, Wilms Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Genetic Variants in INSL3, WT1, and GATA6 Genes
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.
Measured: Up to 3 months after completion of the study
Secondary outcomes (1)
Analysis of Gene Expression Levels in Processus Vaginalis Tissues
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.
Measured: Up to 3 months after completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start9 Sep 2025
- Primary completion10 Apr 2026
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Said Koprulu, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586332
- Sponsor's protocol ID
- 2025/184
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided