Gene Expression and DNA Variation Analysis of Sacs to Identify the Pathophysiology of Indirect Inguinal Hernia

NCT04634032 | Unknown

• 1 other identifier: HerniaOK
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is to show that gene expression levels change in at least one of the GATA6 and T-box transcription factor 3 (TBX3) genes in indirect inguinal hernia sacs, thus revealing that this pathway causes an error in the sac closure pathway. Indirect inguinal hernia is an important condition for human health as it is common in the community and can lead to life-threatening or permanent loss of function. In addition, since the treatment is performed surgically, the follow-up and treatment process of the patients should be managed carefully in terms of complications and costs. By explaining the mechanisms of the occurrence of this disease, important steps will be taken in terms of both human health and the development of science. Moreover, the data to be collected may open new horizons in the treatment of inguinal hernia. 20 inguinal hernia patients those consecutively applied to Trakya University Medical Faculty Department of Pediatric Surgery and 20 circumcision patients as control group will be included in the study.

Conditions

Indirect Inguinal Hernia; Genetic Predisposition to Disease

Keywords

indirect inguinal hernia; GATA6; TBX3; SNP; gene expression

Outcome Measures

Primary Outcomes (1)

• Gene expression and Single Nucleotide Polymorphism analysis

  Determining the varieties of messenger ribonucleic acid (mRNA) expression levels between groups and possible Single Nucleotide Polymorphisms (SNP)

  up to 3 months after completion of the study

Study Arms (2)

Hernia

Patients planned to undergo routine indirect inguinal hernia repair procedure

Genetic: mRNA expression and SNP analysis; Diagnostic Test: Blood sampling

Control

Patients planned to undergo routine circumcision procedure

Genetic: mRNA expression and SNP analysis; Diagnostic Test: Blood sampling

Interventions

mRNA expression and SNP analysis GENETIC

mRNA expression and SNP analysis from samples

Control; Hernia

Blood sampling DIAGNOSTIC_TEST

Peripheral blood sampling for SNP analysis

Control; Hernia

Eligibility Criteria

• Age: Up to 18 Years
• Gender Eligibility Details: Indirect inguinal hernia development differs between both sexes , our study aims to research indirect inguinal hernia in male population
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients applied to the Trakya University Hospital Pediatric Surgery Clinic that meet the inclusion criteria and whose legal representative gave consent to be enrolled included to the study.

You may qualify if:

• to accept to participate the study
• pediatric age
• isolated indirect inguinal hernia patient with no additional systemic/congenital disease
• patients requesting circumcision procedure with no additional systemic/congenital disease

You may not qualify if:

• patients with any syndromic disease
• patients with hypospadias
• patients with undescended testes
• patients with umbilical hernia

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patent processus vaginalis and preputial tissue samples for mRNA expression analysis, peripheral white blood cells for SNP analysis

MeSH Terms

Conditions

Hernia, Inguinal; Genetic Predisposition to Disease

Interventions

Gene Expression; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Genetic Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Oguz Kizilkaya

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 18, 2020
• Study Start: October 22, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 20, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)