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

Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh in a Retrospective Cohort of Clean-Contaminated and Contaminated Retromuscular Ventral Hernia Repairs

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral; Hernia Incisional
• Intervention / Treatment: Device: Medium weight or Heavy weight mesh

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1496

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent open ventral hernia repairs with synthetic mesh in contaminated and clean-contaminated hernia repair surgeries.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medium weight PP mesh; Patients receiving medium weight PP mesh in clean-contaminated and contaminated settings	Device: Medium weight or Heavy weight mesh; 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	Device: Medium weight or Heavy weight mesh; Patients received a hernia repair with one of the two groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complications	Wound complcations	30 days post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesh removal	mesh removal after surgery	30 days post op
Readmissions	readmission or ER visit after surgery	30 days post op
Reoperations	Reoperation after surgery	30 days post op

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Abdominal Core Health Quality Collaborative

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: 23-346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data will not be shared with other researchers other than through peer-reviewed publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No