Hernia, VentralNCT06409091
Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh
An observational study of Hernia, Ventral and Hernia Incisional, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Ventral, Hernia Incisional
- What is being tested?
- Medium weight or Heavy weight mesh
- Type of treatment
- Medical device
- How many people
- 1,496 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 30 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent open ventral hernia repairs with synthetic mesh in contaminated and clean-contaminated hernia repair surgeries.
Who may be able to join
- Patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery
Who cannot join
- Laparoscopic or robotic surgery
- clean cases or dirty cases
- pregnancy
- under age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh in a Retrospective Cohort of Clean-Contaminated and Contaminated Retromuscular Ventral Hernia Repairs
This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.
Read the detailed description
The Abdominal Core Health Quality Collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (PP) mesh and medium weight PP mesh in cases where there was clean-contaminated and contaminated surgeries. The short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.
- Conditions
- Hernia, Ventral, Hernia Incisional
- Being tested
- Medium weight or Heavy weight mesh
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium weight or Heavy weight meshDevice
Patients received a hernia repair with one of the two groups
| Study group | Role | What they receive |
|---|---|---|
| Medium weight PP mesh | Patients receiving medium weight PP mesh in clean-contaminated and contaminated settings Receives: Device: Medium weight or Heavy weight mesh | |
| Heavy Weight PP Mesh | Patients receiving heavy weight PP mesh in clean-contaminated and contaminated settings Receives: Device: Medium weight or Heavy weight mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications
Wound complcations
Measured: 30 days post op
Secondary outcomes (3)
Mesh removal
mesh removal after surgery
Measured: 30 days post op
Readmissions
readmission or ER visit after surgery
Measured: 30 days post op
Reoperations
Reoperation after surgery
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jan 2012
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Beffa, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409091
- Sponsor's protocol ID
- 23-346
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data will not be shared with other researchers other than through peer-reviewed publication
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh in a Retrospective Cohort of Clean-Contaminated and Contaminated Retromuscular Ventral Hernia Repairs
- ClinicalTrials.gov ID
- NCT06409091
- Acronym / sponsor ID
- 23-346
- Conditions
- Hernia, Ventral, Hernia Incisional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,496 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 May 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 compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.
Detailed description
The Abdominal Core Health Quality Collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (PP) mesh and medium weight PP mesh in cases where there was clean-contaminated and contaminated surgeries. The short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium weight PP mesh | – | Device: Medium weight or Heavy weight meshPatients receiving medium weight PP mesh in clean-contaminated and contaminated settings |
| Heavy Weight PP Mesh | – | Device: Medium weight or Heavy weight meshPatients receiving heavy weight PP mesh in clean-contaminated and contaminated settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent open ventral hernia repairs with synthetic mesh in contaminated and clean-contaminated hernia repair surgeries.
Key inclusion criteria (1 listed)
- Patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery
Key exclusion criteria (4 listed)
- Laparoscopic or robotic surgery
- clean cases or dirty cases
- pregnancy
- under age of 18
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 |
|---|---|---|
| Medium weight or Heavy weight meshPatients received a hernia repair with one of the two groups | Device | Heavy Weight PP Mesh, Medium weight PP mesh |
Primary outcome
Wound complications
Time frame: 30 days post op
Wound complcations
3 secondary outcomes
Mesh removal
Time frame: 30 days post op
Readmissions
Time frame: 30 days post op
Reoperations
Time frame: 30 days post op
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 14 May 2024.
- Individual participant dataSharing planned: No. This data will not be shared with other researchers other than through peer-reviewed publication
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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 Hernia, Ventral and Hernia Incisional, run by The Cleveland Clinic 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 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 14 May 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 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?
Wound complications (time frame: 30 days post op). 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 14 May 2024.