Long Term Outcomes Following Hernia Repair With Mesh

Recruiting

• Conditions: Abdominal Hernia

• Registration Number: NCT04578340
• Lead Sponsor: NorthShore University HealthSystem

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-11
• Last Update Posted: 2023-11-14
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4700

Inclusion Criteria

• abdominal hernia repair using mesh

Exclusion Criteria

• less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient quality of life	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	Within 5 years of initial hernia repair	Should the hernia repair fail and the hernia reappears, this is counted as a recurrent hernia.

Secondary Outcome Measures

Name	Time	Method
Postoperative infection rate	Up to 5 years postoperatively	Infection related to hernia repair or mesh use will be reported.

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States