Long Term Outcomes Following Hernia Repair With Mesh

November 11, 2023 updated by: Michael Ujiki MD, NorthShore University HealthSystem
The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University Healthsystem
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Ujiki, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Multihospital system inclusive of all abdominal hernia repairs using mesh

Description

Inclusion Criteria:

  • abdominal hernia repair using mesh

Exclusion Criteria:

  • less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence rate
Time Frame: Within 5 years of initial hernia repair
Should the hernia repair fail and the hernia reappears, this is counted as a recurrent hernia.
Within 5 years of initial hernia repair
Patient quality of life
Time Frame: Up to 5 years postopertively
Quality of life before and after surgery will be compared using various self-reported assessment tools/questionnaires.
Up to 5 years postopertively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative infection rate
Time Frame: Up to 5 years postoperatively
Infection related to hernia repair or mesh use will be reported.
Up to 5 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH20-388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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