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Trial record 2 of 236 for:    Recruiting, Not yet recruiting Studies | hernia

Mesh Type in Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT03091790
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mike K Liang, The University of Texas Health Science Center, Houston

Brief Summary:
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.

Condition or disease Intervention/treatment Phase
Ventral Hernia Device: Synthetic Mesh Device: Biologic Mesh Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mesh Type in Ventral Hernia Repair
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Synthetic Mesh
Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair
Device: Synthetic Mesh
Synthetic mesh used during open ventral hernia repair

Active Comparator: Biologic Mesh
Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair
Device: Biologic Mesh
Biologic mesh used during open ventral hernia repair




Primary Outcome Measures :
  1. Complication free at 1 year post-operative [ Time Frame: 1 year after surgery ]
    Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation


Secondary Outcome Measures :
  1. Complication free at 3 years post-operative [ Time Frame: 3 years after surgery ]
    Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation

  2. Dindo-clavien complications [ Time Frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery ]
    Grade I to V

  3. Patient centered outcomes [ Time Frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery ]
    includes patient satisfaction, cosmetic satisfaction, modified assessment scale

  4. Cost [ Time Frame: 1 year and 3 years after surgery ]
    charges for all patient visits, admissions, and procedures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient scheduled for open ventral hernia repair at LBJ General Hospital

Exclusion Criteria:

  • Active infection
  • Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
  • Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
  • Patient unlikely to follow-up (i.e. no phone)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091790


Contacts
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Contact: Mike Liang, M.D. 713-566-5095 Mike.K.Liang@uth.tmc.edu
Contact: Debbie F Lew, M.P.H. 713-566-5097 Debbie.F.Lew@uth.tmc.edu

Locations
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United States, Texas
UT Health at Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Contact: Mike K Liang, M.D.    713-566-5095    Mike.K.Liang@uth.tmc.edu   
Contact: Debbie F Lew, M.P.H.    713-566-5097    Debbie.F.Lew@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Mike Liang, M.D. UT Health

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Responsible Party: Mike K Liang, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03091790     History of Changes
Other Study ID Numbers: HSC-MS-16-0936
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mike K Liang, The University of Texas Health Science Center, Houston:
ventral hernia
mesh
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal