Long-Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Completed

• Conditions: Ventral Hernia

• Registration Number: NCT04853550
• Lead Sponsor: University of Louisville

Brief Summary

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

Detailed Description

Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Hernia repair with Strattice Mesh
• Age 18 or older

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Exclusion Criteria

• Under age 18
• No history of hernia repair

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	24 Months	Percentage of patients with recurrence at long-term (\>12 months) follow-up.

Secondary Outcome Measures

Name	Time	Method
Quality of LIfe Questionnaire	24 Months	Percentage of patients with mean quality of life scores at long-term (\>12 months) follow-up.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States