Long Term Outcomes Following Hernia Repair With Mesh
1 other identifier
observational
4,700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedNovember 14, 2023
November 1, 2023
5 years
October 1, 2020
November 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Postoperative infection rate
Up to 5 years postoperatively
Eligibility Criteria
Multihospital system inclusive of all abdominal hernia repairs using mesh
You may qualify if:
- abdominal hernia repair using mesh
You may not qualify if:
- less than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
- Medtroniccollaborator
Study Sites (1)
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Minimally Invasive Surgery; Chief, Division of Gastrointestinal and General Surgery
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 8, 2020
Study Start
October 1, 2020
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
November 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share