Adults 18 to 90, any sex, with Ventral Hernia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pain ScoresPrimary· One Year Postoperatively
Pain Scores will be measured using the NIH Promis 3A Pain Scale. PROMIS® Pain Intensity 3A is a three-question instrument developed to measure the range of pain experienced in the week prior to assessment. The raw score (3-15) is converted into a T-score where 50 (SD 10) represents the average of people with at least mild pain, higher numbers (maximum 71.8) represent higher than average pain, and the lowest score (30.7) represents no pain.
Group
Value
95% CI
Heavy Weight Mesh
30.7
30.7 – 43.5
Medium Weight Mesh
30.7
30.7 – 40.2
Number of Subjects With Hernia RecurrenceSecondary· One Year Postoperatively
Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.
Physical Exam
Group
Value
95% CI
Heavy Weight Mesh
2
Medium Weight Mesh
4
Hernia Recurrence Inventory (HRI)- assessed by subject answering "Yes" to bulge on questionnaire
Group
Value
95% CI
Heavy Weight Mesh
52
Medium Weight Mesh
62
Radiographic- assessed using CT scan
Group
Value
95% CI
Heavy Weight Mesh
3
Medium Weight Mesh
3
Composite Hernia Recurrence (Consensus)- Saying yes to bulge, or having a hernia on imaging or exam
Group
Value
95% CI
Heavy Weight Mesh
14
Medium Weight Mesh
13
Composite Hernia Recurrence (max Sn) includes subjects answering bulge yes and no further follow up
Group
Value
95% CI
Heavy Weight Mesh
42
Medium Weight Mesh
48
Composite Hernia Recurrence (max Sp) includes subjects with only imaging or clinical exam
Group
Value
95% CI
Heavy Weight Mesh
3
Medium Weight Mesh
4
Deep Wound InfectionSecondary· 30-Days Postoperatively
The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.
Group
Value
95% CI
Heavy Weight Mesh
3
Medium Weight Mesh
5
Quality of Life ScoresSecondary· One Year Postoperatively
Quality of life will be measured using the HerQLes quality of life questionnaire. HerQLes is a twelve-question instrument developed to evaluate quality of life and function as it pertains to the abdominal wall. It is converted into a 0-100 scale with 0 representing poor abdominal wall function, and 100 excellent function.
Group
Value
95% CI
Heavy Weight Mesh
90
67.92 – 96.67
Medium Weight Mesh
86.67
65 – 93.33
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year following surgery for hernia repair.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 14 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03082391.