CClinicalTrials.gg
RecruitingNCT04578340Updated Nov 14, 2023

Long Term Outcomes Following Hernia Repair With Mesh

An observational study in Abdominal Hernia, sponsored by Endeavor Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by Endeavor Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,700
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Multihospital system inclusive of all abdominal hernia repairs using mesh

Inclusion criteria

  • abdominal hernia repair using mesh

Exclusion criteria

Exclusion Criteria:

  • less than 18 years old
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,700 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Hernia recurrence rate

    Should the hernia repair fail and the hernia reappears, this is counted as a recurrent hernia.

    Time frame: Within 5 years of initial hernia repair

  2. Patient quality of life

    Quality of life before and after surgery will be compared using various self-reported assessment tools/questionnaires.

    Time frame: Up to 5 years postopertively

Secondary outcomes

  1. Postoperative infection rate

    Infection related to hernia repair or mesh use will be reported.

    Time frame: Up to 5 years postoperatively

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Study locations

1 of 1 sites recruiting
  • NorthShore University HealthSystem
    Evanston, Illinois 60201, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04578340
Lead sponsor
Endeavor Health
Collaborators
Medtronic
Responsible party
Michael Ujiki MD (Director of Minimally Invasive Surgery; Chief, Division of Gastrointestinal and General Surgery, Endeavor Health) — Principal investigator
First posted
Oct 8, 2020
Start date
Oct 1, 2020
Primary completion
Oct 1, 2025 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Nov 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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