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Ventral Incisional HerniaNCT03317665

Observational Biologic or Prosthetic Mesh

An observational study of Ventral Incisional Hernia, run by University of South Florida at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventral Incisional Hernia
What is being tested?
Mesh for hernia repair
Type of treatment
Medical device
How many people
28 participants
Where
3 sitesUnited States
Study dates
11 Feb 2019to 11 Jun 2021
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients requiring open ventral hernia repair.

Who may be able to join

  • Male and female patients > 21 years old.
  • Able to provide informed consent in English or Spanish.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.

Who cannot join

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
  • Allergy or hypersensitivity to materials in porcine-based study products, prosthetic or biological meshes, or personal preference.
  • Male and female patients ≤ 21 years old
  • History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up.
  • Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of South Florida - South Tampa Campus

    Tampa, Florida, 33606

  • University of South Florida Morsani Center for Advanced Health Care

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Prospective, Observational Trial of Biological or Prosthetic Mesh for Open Ventral Hernia Repair

The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.

Read the detailed description

Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate.

Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.

Being tested
Mesh for hernia repair
Keywords
biologic, prosthetic, mesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesh for hernia repairDevice

    Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.

Study groups in NCT03317665
Study groupRoleWhat they receive
Standard of careMesh for hernia repair: Standard of care products used by the Investigator for open ventral hernia repair procedure
Receives: Device: Mesh for hernia repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ventral hernia recurrence

    Measured: 2 years from study ventral hernia repair

Secondary outcomes (11)

  1. Time to ventral hernia recurrence

    Measured: 2 years from study ventral hernia repair

  2. Incidence of wound complications

    Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation

    Measured: 90 days from study ventral hernia repair

  3. Incidence of enterocutaneous fistula formation

    Measured: 2 years from study ventral hernia repair

  4. Mean Carolinas Comfort Scale score

    Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115

    Measured: 2 years from study ventral hernia repair

  5. Mean Visual Analog Scale score

    Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable)

    Measured: 2 years from study ventral hernia repair

  6. Mean mesh deployment time

    Defined as the time mesh preparation starts to time mesh placement ends

    Measured: during surgery

  7. Mean procedure time

    Defined as time of incision to time of closure

    Measured: during surgery

  8. Mean total cost of hospitalization for primary admission

    Defined as cost from surgery to hospital discharge

    Measured: From date of surgery to date of hospital discharge (approximately 3 days)

  9. Mean total cost of surgery for primary admission

    Defined as cost from preoperative preparation to anesthesia discharge

    Measured: during surgery

  10. Mean total cost of narcotic usage for primary admission

    Defined as cost from narcotic use from surgery to hospital discharge

    Measured: From date of surgery to date of hospital discharge (approximately 3 days)

  11. Mean total cost of readmissions

    any hospital readmissions related to ventral hernia complications or recurrence

    Measured: 2 years from study ventral hernia repair

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start11 Feb 2019
  3. Primary completion11 Jun 2021
  4. Study completion11 Jun 2021

Why it stopped: Premature termination due to cease of funding

Resources

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
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317665
Sponsor's protocol ID
CA2017-003
Status last verified
Sep 2021
First submitted
10 Oct 2017
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Fekkes JF, Velanovich V. Amelioration of the effects of obesity on short-term postoperative complications of laparoscopic and open ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2015 Apr;25(2):151-7. doi: 10.1097/SLE.0000000000000100.

    PubMed 25222715

  • Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.

    PubMed 21904861

  • Fischer JP, Wink JD, Tuggle CT, Nelson JA, Kovach SJ. Wound risk assessment in ventral hernia repair: generation and internal validation of a risk stratification system using the ACS-NSQIP. Hernia. 2015 Feb;19(1):103-11. doi: 10.1007/s10029-014-1318-5. Epub 2014 Dec 4.

    PubMed 25472771

  • Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.

    PubMed 9382393

  • Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.

    PubMed 26206646

  • Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.

    PubMed 18387468

  • Nielsen K, Poelman MM, den Bakker FM, van der Ploeg T, Bonjer HJ, Schreurs WH. Comparison of the Dutch and English versions of the Carolinas Comfort Scale: a specific quality-of-life questionnaire for abdominal hernia repairs with mesh. Hernia. 2014 Aug;18(4):459-64. doi: 10.1007/s10029-013-1173-9. Epub 2013 Oct 29.

    PubMed 24166693

  • FitzGerald JF, Kumar AS. Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons? Clin Colon Rectal Surg. 2014 Dec;27(4):140-8. doi: 10.1055/s-0034-1394155.

    PubMed 26106284

  • Aravot DJ, Banner NR, Khaghani A, Fitzgerald M, Radley-Smith R, Mitchell AG, Yacoub MH. Cardiac transplantation in the seventh decade of life. Am J Cardiol. 1989 Jan 1;63(1):90-3. doi: 10.1016/0002-9149(89)91082-5.

    PubMed 2642367

Questions about this trial

What is this clinical trial studying?

An observational study of Ventral Incisional Hernia, run by University of South Florida at 3 sites 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 was stopped early (reason given: Premature termination due to cease of funding). 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?

Incidence of ventral hernia recurrence (time frame: 2 years from study ventral hernia repair). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317665, which also lists 9 linked publications.

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 6 Oct 2021.

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