An observational study in Indirect Inguinal Hernia and Undescended Testis, sponsored by Trakya University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to male participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Trakya University · Observational
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.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 3 is below the median of 134 across 137 observational studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.
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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.
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Exclusion Criteria:
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.
Time frame: Up to 3 months after completion of the study
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.
Time frame: Up to 3 months after completion of the study
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Apr 2026, 7 months.
Of 51 non-industry observational studies under Hernia, Inguinal, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 68. This study's 7 months is below that.
Counting every sponsor, half of 57 studies reached it within 18 months; a quarter within 9 and three quarters within 68.
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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