Clinical trial NCT03317665: Observational Biologic or Prosthetic Mesh
Official title: Prospective, Observational Trial of Biological or Prosthetic Mesh for Open Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventral Incisional Hernia
Keywords: biologic
prosthetic
mesh
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2017-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring open ventral hernia repair.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of ventral hernia recurrence
timeFrame: 2 years from study ventral hernia repair
Secondary outcomes:
measure: Time to ventral hernia recurrence
timeFrame: 2 years from study ventral hernia repair
measure: Incidence of wound complications
timeFrame: 90 days from study ventral hernia repair
measure: Incidence of enterocutaneous fistula formation
timeFrame: 2 years from study ventral hernia repair
measure: Mean Carolinas Comfort Scale score
timeFrame: 2 years from study ventral hernia repair
measure: Mean Visual Analog Scale score
timeFrame: 2 years from study ventral hernia repair
measure: Mean mesh deployment time
timeFrame: during surgery
measure: Mean procedure time
timeFrame: during surgery
measure: Mean total cost of hospitalization for primary admission
timeFrame: From date of surgery to date of hospital discharge (approximately 3 days)
measure: Mean total cost of surgery for primary admission
timeFrame: during surgery
measure: Mean total cost of narcotic usage for primary admission
timeFrame: From date of surgery to date of hospital discharge (approximately 3 days)
measure: Mean total cost of readmissions
timeFrame: 2 years from study ventral hernia repair
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida - South Tampa Campus
state: Florida
city: Tampa
country: United States
facility: University of South Florida Morsani Center for Advanced Health Care
state: Florida
Study officials:
affiliation: University of South Florida
name: Vic Velanovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.