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Clinical Trials/NCT04578340
NCT04578340
Recruiting
Not Applicable

Long Term Outcomes Following Hernia Repair With Mesh

NorthShore University HealthSystem1 site in 1 country4,700 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Hernia
Sponsor
NorthShore University HealthSystem
Enrollment
4700
Locations
1
Primary Endpoint
Patient quality of life
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
October 1, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Ujiki MD

Director of Minimally Invasive Surgery; Chief, Division of Gastrointestinal and General Surgery

NorthShore University HealthSystem

Eligibility Criteria

Inclusion Criteria

  • abdominal hernia repair using mesh

Exclusion Criteria

  • less than 18 years old

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Postoperative infection rate(Up to 5 years postoperatively)

Study Sites (1)

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