NCT04853550

Brief Summary

This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

April 16, 2021

Last Update Submit

June 28, 2023

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

    Percentage of patients with recurrence at long-term (\>12 months) follow-up.

    24 Months

Secondary Outcomes (1)

  • Quality of LIfe Questionnaire

    24 Months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who have undergone ventral hernia repair with Strattice Mesh between January 1, 2013 and November 1, 2019

You may qualify if:

  • Hernia repair with Strattice Mesh
  • Age 18 or older

You may not qualify if:

  • Under age 18
  • No history of hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Farid Kehdy, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

November 13, 2019

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

US(1)