Ventral HerniaNCT04853550
Long-Term Follow-up After Ventral Hernia Repair With Strattice Mesh
An observational study of Ventral Hernia, run by University of Louisville at 1 site in United States.
Trial summary
This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Strattice Mesh
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 14 Nov 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who have undergone ventral hernia repair with Strattice Mesh between January 1, 2013 and November 1, 2019
Who may be able to join
- Hernia repair with Strattice Mesh
- Age 18 or older
Who cannot join
- Under age 18
- No history of hernia repair
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Long Term Follow-up After Ventral Hernia Repair With Strattice Mesh
This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.
Read the detailed description
Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.
- Conditions
- Ventral Hernia
- Being tested
- Strattice Mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattice MeshDevice
Subjects will be restrospectively identified has having undergone ventral hernia repair with Strattice mesh reinforcement. Once identified long term follow-up data will be collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Percentage of patients with recurrence at long-term (>12 months) follow-up.
Measured: 24 Months
Secondary outcomes (1)
Quality of LIfe Questionnaire
Percentage of patients with mean quality of life scores at long-term (>12 months) follow-up.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start13 Nov 2019
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- AllerGen NCE Inc.
- Responsible party
- Principal investigator, Farid Kehdy, University of Louisville
- Investigators
- Farid Kehdy, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853550
- Sponsor's protocol ID
- 19.0980
- Status last verified
- Jun 2023
- First submitted
- 16 Apr 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up After Ventral Hernia Repair With Strattice Mesh
- ClinicalTrials.gov ID
- NCT04853550
- Acronym / sponsor ID
- 19.0980
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- AllerGen NCE Inc.
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 21 Apr 2021 (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 will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.
Detailed description
Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone ventral hernia repair with Strattice Mesh between January 1, 2013 and November 1, 2019
Key inclusion criteria (2 listed)
- Hernia repair with Strattice Mesh
- Age 18 or older
Key exclusion criteria (2 listed)
- Under age 18
- No history of hernia repair
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 |
|---|---|---|
| Strattice MeshSubjects will be restrospectively identified has having undergone ventral hernia repair with Strattice mesh reinforcement. Once identified long term follow-up data will be collected. | Device | – |
Primary outcome
Hernia recurrence
Time frame: 24 Months
Percentage of patients with recurrence at long-term (>12 months) follow-up.
1 secondary outcome
Quality of LIfe Questionnaire
Time frame: 24 Months
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 3 Jul 2023.
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
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.
Farid Kehdy, MD principal investigator
University of Louisville
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 Ventral Hernia, run by University of Louisville at 1 site in United States.
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 2 inclusion and 2 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 3 Jul 2023. 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 United States. 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?
Hernia recurrence (time frame: 24 Months). 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 3 Jul 2023.