N/A
N=350
Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT03082391 ↗Enrolled (actual)
350
Serious AEs
8.3%
Results posted
Jun 2022
Primary outcome: Primary: Pain Scores — 30.7; 30.7 T-Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heavy weight Mesh (Device); Medium weight Mesh (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores |
30.7; 30.7 | — |
| SECONDARY Number of Subjects With Hernia Recurrence |
2; 4; 52; 62; 3; 3 | — |
| SECONDARY Deep Wound Infection |
3; 5 | — |
| SECONDARY Quality of Life Scores |
90; 86.67 | — |
Summary
The purpose of this study is to determine if mesh weight has an impact on postoperative pain, ventral hernia recurrence, incidence of deep wound infection, and overall quality of life following ventral hernia repair with mesh.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Will undergo a single-stage, open, retromuscular ventral hernia repair
- CDC Wound Class 1
- Able to achieve midline fascial closure
- Hernia defect width less than or equal to 20 centimeters (measured intraoperatively)
- Able to tolerate general anesthesia
- Able to give informed consent
Exclusion Criteria
- Patients who are less than 18 years of age
- Patients who undergo emergent ventral hernia repair
- Patients who undergo laparoscopic or robotic ventral hernia repair
- Patients with CDC Wound Class 2, 3, or 4
- Patients who are unable to undergo successful retromuscular mesh placement or who cannot achieve midline fascial closure
- Patients who undergo staged repair of their ventral hernia
- Patients who are unable to give informed consent
- Patients who cannot tolerate general anesthesia
- Patients who are pregnant at the time of surgical intervention
Data sourced from ClinicalTrials.gov (NCT03082391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.