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

Hernia, Ventral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06409091
• Other study ID #: 23-346
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1496
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Hernia, Ventral
• Incisional Hernia

Intervention

Device:
• Medium weight or Heavy weight mesh
Patients received a hernia repair with one of the two groups

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound complications	Wound complcations	30 days post op
Secondary	Mesh removal	mesh removal after surgery	30 days post op
Secondary	Readmissions	readmission or ER visit after surgery	30 days post op
Secondary	Reoperations	Reoperation after surgery	30 days post op