Indirect Inguinal HerniaNCT04634032
Gene Expression and DNA Variation Analysis of Sacs to Identify the Pathophysiology of Indirect Inguinal Hernia
An observational study of Indirect Inguinal Hernia and Genetic Predisposition to Disease, run by Trakya University at 1 site in Turkey (Türkiye).
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. 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, Genetic Predisposition to Disease
- What is being tested?
- mRNA expression and SNP analysis and Blood sampling
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2019to 20 Nov 2020
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
Who may be able to join
- 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
Who cannot join
- patients with any syndromic disease
- patients with hypospadias
- patients with undescended testes
- patients with umbilical hernia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- mRNA expression and SNP analysis, Blood sampling
- Keywords
- indirect inguinal hernia, GATA6, TBX3, SNP, gene expression
- Medical subject headings
- Hernia, Inguinal, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA expression and SNP analysisGenetic
mRNA expression and SNP analysis from samples
Blood samplingDiagnostic test
Peripheral blood sampling for SNP analysis
| Study group | Role | What they receive |
|---|---|---|
| Hernia | Patients planned to undergo routine indirect inguinal hernia repair procedure Receives: Genetic: mRNA expression and SNP analysis; Diagnostic Test: Blood sampling | |
| Control | Patients planned to undergo routine circumcision procedure Receives: Genetic: mRNA expression and SNP analysis; Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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 posted18 Nov 2020
- Study start22 Oct 2019
- Primary completion1 Nov 2020
- Study completion20 Nov 2020 (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
- 40 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Kizilkaya, Trakya University
- Investigators
- Oguz Kizilkaya, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634032
- Sponsor's protocol ID
- HerniaOK
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the data at this time but it may be possible after completion of the publication process.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression and DNA Variation Analysis of Sacs to Identify the Pathophysiology of Indirect Inguinal Hernia
- ClinicalTrials.gov ID
- NCT04634032
- Acronym / sponsor ID
- HerniaOK
- Keywords
- indirect inguinal hernia, GATA6, TBX3, SNP, gene expression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hernia | – | Genetic: mRNA expression and SNP analysis, Diagnostic Test: Blood samplingPatients planned to undergo routine indirect inguinal hernia repair procedure |
| Control | – | Genetic: mRNA expression and SNP analysis, Diagnostic Test: Blood samplingPatients planned to undergo routine circumcision procedure |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- patients with any syndromic disease
- patients with hypospadias
- patients with undescended testes
- patients with umbilical hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA expression and SNP analysismRNA expression and SNP analysis from samples | Genetic | Control, Hernia |
| Blood samplingPeripheral blood sampling for SNP analysis | Diagnostic test | Control, Hernia |
Primary outcome
Gene expression and Single Nucleotide Polymorphism analysis
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No. There is no plan to share the data at this time but it may be possible after completion of the publication process.
Related trials for Indirect Inguinal Hernia
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oguz Kizilkaya principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indirect Inguinal Hernia and Genetic Predisposition to Disease, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression and Single Nucleotide Polymorphism analysis (time frame: up to 3 months after completion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.