Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh

NCT ID: NCT06409091

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1496 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2023-06-30

Brief Summary

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This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.

Detailed Description

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The Abdominal Core Health Quality Collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (PP) mesh and medium weight PP mesh in cases where there was clean-contaminated and contaminated surgeries. The short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.

Conditions

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Hernia, Ventral Hernia Incisional

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Medium weight PP mesh

Patients receiving medium weight PP mesh in clean-contaminated and contaminated settings

Medium weight or Heavy weight mesh

Intervention Type DEVICE

Patients received a hernia repair with one of the two groups

Heavy Weight PP Mesh

Patients receiving heavy weight PP mesh in clean-contaminated and contaminated settings

Medium weight or Heavy weight mesh

Intervention Type DEVICE

Patients received a hernia repair with one of the two groups

Interventions

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Medium weight or Heavy weight mesh

Patients received a hernia repair with one of the two groups

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery

Exclusion Criteria

* Laparoscopic or robotic surgery
* clean cases or dirty cases
* pregnancy
* under age of 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Lucas Beffa

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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23-346

Identifier Type: -

Identifier Source: org_study_id

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