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临床试验/NCT04634032
NCT04634032Unknown不适用

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

Trakya University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Gene expression and Single Nucleotide Polymorphism analysis

研究概览

简要总结

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.

详细描述

Indirect inguinal hernia is one of the pathologies that is widely researched in national and international studies because of its high prevalence in the community and its life-threatening or permanent loss of function. However, no point has been reached regarding the etiology of this disease and a consensus has been reached.

The investigators believe that the study will contribute to the explanation of the formation mechanisms of the mentioned disease. Considering the high prevalence of this disease and its potential for life-threatening, the investigators anticipate that the analysis of the relevant genes for the Turkish population will make significant contributions to the public health. In the literature, analysis of GATA6 SNPs in the Chinese population has subsequently associated certain polymorphisms with indirect inguinal hernia. It is also been stated that TBX3 gene pathologies may be associated with inguinal hernia.

However, there is no study in the literature about the patent processus vaginalis expression levels of these genes. There is no study on the SNP analysis of these genes in Turkish population. For these reasons, the first time the expression / SNP analysis of the specified genes in Turkish society will be carried out will make an additional contribution to scientific knowledge. As stated clearly in the studies, the implementation of medical treatment of indirect inguinal hernia may change the approach of the pediatric surgical community to indirect inguinal hernia. In order for medical treatment to be carried out, the formation pathways and genetic origins of the disease must be clearly revealed.

Investigating the relationship of GATA6 and TBX3 genes, which are known to be involved in connective tissue homeostasis, with the mechanisms of indirect inguinal hernia formation, will contribute to the studies in the literature and is important in terms of revealing whether the treatment of these diseases can be performed medically in the future.

The study aims to reveal that gene expression levels in indirect inguinal hernia sacs due to SNPs in at least one of the GATA6 and TBX3 genes, thus causing an error in the sac closure pathway. The hypothesis of the study; It is stated that the gene expression levels of at least one of GATA6 and TBX3 in the sacs of inguinal hernia patients are altered.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Gene expression and Single Nucleotide Polymorphism analysis

时间窗: up to 3 months after completion of the study

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oguz Kizilkaya

Resident

Trakya University

研究点 (1)

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