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NCT04578340 Clinical Trial

Long Term Outcomes Following Hernia Repair With Mesh

Abdominal Hernia Clinical Trial

Official title:
Long Term Outcomes Following Hernia Repair With Mesh

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04578340
Other study ID # EH20-388
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2026

Study information
Verified date November 2023
Source NorthShore University HealthSystem
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

Description:

This is a large scale registry of prospectively collected medical record data and self-reported outcomes for those patients undergoing abdominal hernia repair with mesh.

Recruitment information / eligibility
Status Recruiting
Enrollment 4700
Est. completion date October 1, 2026
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - abdominal hernia repair using mesh Exclusion Criteria: - less than 18 years old

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States NorthShore University HealthSystem Evanston Illinois

Sponsors (2)
Lead Sponsor Collaborator
NorthShore University HealthSystem Medtronic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hernia recurrence rate Should the hernia repair fail and the hernia reappears, this is counted as a recurrent hernia. Within 5 years of initial hernia repair
Primary Patient quality of life Quality of life before and after surgery will be compared using various self-reported assessment tools/questionnaires. Up to 5 years postopertively
Secondary Postoperative infection rate Infection related to hernia repair or mesh use will be reported. Up to 5 years postoperatively
See also
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Completed NCT04435340 - Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh N/A
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Not yet recruiting NCT05606757 - A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique Phase 2