Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04634032 |
| Other study ID # |
HerniaOK |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 22, 2019 |
| Est. completion date |
November 20, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
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.
The primary goal of this study is; To determine the level of GATA6 and TBX3 gene expression
in sacs obtained from indirect inguinal hernia patients. The secondary goal is to investigate
SNPs in the leukocytes of these patients and to investigate whether the genetic elements in
our hypothesis in these diseases are regulated by different genes acting as transcription
factors.
Considering that indirect inguinal hernia poses significant health risks, especially in
children, it is predicted that the results to be obtained may contribute to clarification of
the etiology and non-invasive methods other than surgery.
