Incisional HerniaNCT06366581
Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology
An observational study of Incisional Hernia and Extracellular Matrix Alteration, run by Fudan University at 1 site in China.
Trial summary
This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia, Extracellular Matrix Alteration
- What is being tested?
- Transcriptomic analysis
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Mar 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group), and patients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group).
Who may be able to join
- 1.18 to 75 years 2.diagnosed with incisional hernia 3.normal tumour markers 4.elective surgery patients.
Who cannot join
- patients with vital organ failure (heart liver, lung, kidney and others)
- malignant tumors not been completely relieved by active treatment,
- patients who have psychiatric diseases or comprehension disorders.
- patients with metabolic disease involving connective tissue collagen.
Trial locations and contacts
1 site in 1 country.
About this study
This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix.
- Conditions
- Incisional Hernia, Extracellular Matrix Alteration
- Being tested
- Transcriptomic analysis
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcriptomic analysisDiagnostic test
high-throughput sequencing technology
| Study group | Role | What they receive |
|---|---|---|
| IH group | Patients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group) Receives: Diagnostic Test: Transcriptomic analysis | |
| NC group | patients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group) Receives: Diagnostic Test: Transcriptomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the gene expression list
the gene expression list
Measured: 2023.3-2023.9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366581
- Sponsor's protocol ID
- HD20240307
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology
- ClinicalTrials.gov ID
- NCT06366581
- Acronym / sponsor ID
- HD20240307
- Conditions
- Incisional Hernia, Extracellular Matrix Alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 16 Apr 2024 (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.
This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IH group | – | Diagnostic Test: Transcriptomic analysisPatients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group) |
| NC group | – | Diagnostic Test: Transcriptomic analysispatients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group), and patients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group).
Key inclusion criteria (1 listed)
- 1.18 to 75 years 2.diagnosed with incisional hernia 3.normal tumour markers 4.elective surgery patients.
Key exclusion criteria (4 listed)
- patients with vital organ failure (heart liver, lung, kidney and others)
- malignant tumors not been completely relieved by active treatment,
- patients who have psychiatric diseases or comprehension disorders.
- patients with metabolic disease involving connective tissue collagen.
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 |
|---|---|---|
| Transcriptomic analysishigh-throughput sequencing technology | Diagnostic test | IH group, NC group |
Primary outcome
the gene expression list
Time frame: 2023.3-2023.9
the gene expression list
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Incisional Hernia and Extracellular Matrix Alteration, run by Fudan University at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 16 Apr 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the gene expression list (time frame: 2023.3-2023.9). 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 16 Apr 2024.