Trial Outcomes & Findings for Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair (NCT NCT03082391)
NCT ID: NCT03082391
Last Updated: 2022-07-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
One Year Postoperatively
Results posted on
2022-07-14
Participant Flow
Participant milestones
| Measure |
Heavy Weight Mesh
Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.
Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.
|
Medium Weight Mesh
Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.
Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.
Medium weight Mesh: Patients will undergo ventral hernia repair with medium weight mesh.
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
177
|
|
Overall Study
COMPLETED
|
173
|
177
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Heavy Weight Mesh
n=173 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
|
Medium Weight Mesh
n=177 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.15 Years
STANDARD_DEVIATION 11.35 • n=173 Participants
|
59.31 Years
STANDARD_DEVIATION 11.36 • n=177 Participants
|
59.23 Years
STANDARD_DEVIATION 11.34 • n=350 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=173 Participants
|
91 Participants
n=177 Participants
|
175 Participants
n=350 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=173 Participants
|
86 Participants
n=177 Participants
|
175 Participants
n=350 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
173 participants
n=173 Participants
|
177 participants
n=177 Participants
|
350 participants
n=350 Participants
|
PRIMARY outcome
Timeframe: One Year PostoperativelyPain 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.
Outcome measures
| Measure |
Heavy Weight Mesh
n=173 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
|
Medium Weight Mesh
n=177 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh.
|
|---|---|---|
|
Pain Scores
|
30.7 T-Score
Interval 30.7 to 43.5
|
30.7 T-Score
Interval 30.7 to 40.2
|
SECONDARY outcome
Timeframe: One Year PostoperativelyPopulation: All subjects for both arms were assessed for hernia recurrence, numbers reported below are the number who had recurrence through the following methods of assessment. Some subjects will be in multiple categories
Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.
Outcome measures
| Measure |
Heavy Weight Mesh
n=173 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
|
Medium Weight Mesh
n=177 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh.
|
|---|---|---|
|
Number of Subjects With Hernia Recurrence
Physical Exam
|
2 participants
|
4 participants
|
|
Number of Subjects With Hernia Recurrence
Hernia Recurrence Inventory (HRI)- assessed by subject answering "Yes" to bulge on questionnaire
|
52 participants
|
62 participants
|
|
Number of Subjects With Hernia Recurrence
Radiographic- assessed using CT scan
|
3 participants
|
3 participants
|
|
Number of Subjects With Hernia Recurrence
Composite Hernia Recurrence (Consensus)- Saying yes to bulge, or having a hernia on imaging or exam
|
14 participants
|
13 participants
|
|
Number of Subjects With Hernia Recurrence
Composite Hernia Recurrence (max Sn) includes subjects answering bulge yes and no further follow up
|
42 participants
|
48 participants
|
|
Number of Subjects With Hernia Recurrence
Composite Hernia Recurrence (max Sp) includes subjects with only imaging or clinical exam
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 30-Days PostoperativelyThe occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.
Outcome measures
| Measure |
Heavy Weight Mesh
n=173 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
|
Medium Weight Mesh
n=177 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh.
|
|---|---|---|
|
Deep Wound Infection
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: One Year PostoperativelyQuality 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.
Outcome measures
| Measure |
Heavy Weight Mesh
n=173 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
|
Medium Weight Mesh
n=177 Participants
Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh.
|
|---|---|---|
|
Quality of Life Scores
|
90 score on a scale
Interval 67.92 to 96.67
|
86.67 score on a scale
Interval 65.0 to 93.33
|
Adverse Events
Heavy Weight Mesh
Serious events: 12 serious events
Other events: 46 other events
Deaths: 0 deaths
Medium Weight Mesh
Serious events: 17 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Heavy Weight Mesh
n=173 participants at risk
Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.
Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.
|
Medium Weight Mesh
n=177 participants at risk
Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.
Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.
Medium weight Mesh: Patients will undergo ventral hernia repair with medium weight mesh.
|
|---|---|---|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
1.7%
3/177 • Number of events 3 • 1 year following surgery for hernia repair
|
|
Vascular disorders
Pulmonary Embolism
|
1.2%
2/173 • Number of events 2 • 1 year following surgery for hernia repair
|
3.4%
6/177 • Number of events 6 • 1 year following surgery for hernia repair
|
|
Nervous system disorders
Stroke
|
1.2%
2/173 • Number of events 2 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
1.2%
2/173 • Number of events 2 • 1 year following surgery for hernia repair
|
2.3%
4/177 • Number of events 4 • 1 year following surgery for hernia repair
|
|
Surgical and medical procedures
Excessive Bleeding
|
1.2%
2/173 • Number of events 2 • 1 year following surgery for hernia repair
|
1.1%
2/177 • Number of events 2 • 1 year following surgery for hernia repair
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/173 • 1 year following surgery for hernia repair
|
1.1%
2/177 • Number of events 2 • 1 year following surgery for hernia repair
|
|
Cardiac disorders
Atrial Fibrillation
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
|
Renal and urinary disorders
Renal Failure
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
|
Infections and infestations
Pneumonia
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
Other adverse events
| Measure |
Heavy Weight Mesh
n=173 participants at risk
Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.
Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.
|
Medium Weight Mesh
n=177 participants at risk
Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.
Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh.
Medium weight Mesh: Patients will undergo ventral hernia repair with medium weight mesh.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
1.2%
2/173 • Number of events 2 • 1 year following surgery for hernia repair
|
1.1%
2/177 • Number of events 2 • 1 year following surgery for hernia repair
|
|
Gastrointestinal disorders
Bowel Obstruction
|
4.6%
8/173 • Number of events 8 • 1 year following surgery for hernia repair
|
2.3%
4/177 • Number of events 4 • 1 year following surgery for hernia repair
|
|
Infections and infestations
Cellulitis
|
1.2%
2/173 • Number of events 2 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
|
Gastrointestinal disorders
Colon Cancer
|
0.00%
0/173 • 1 year following surgery for hernia repair
|
0.56%
1/177 • Number of events 1 • 1 year following surgery for hernia repair
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.56%
1/177 • Number of events 1 • 1 year following surgery for hernia repair
|
|
Gastrointestinal disorders
Diarrhea
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
|
Infections and infestations
Gastroenteritis
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
|
Blood and lymphatic system disorders
Hematoma
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.56%
1/177 • Number of events 1 • 1 year following surgery for hernia repair
|
|
Gastrointestinal disorders
Ileus
|
10.4%
18/173 • Number of events 18 • 1 year following surgery for hernia repair
|
17.5%
31/177 • Number of events 31 • 1 year following surgery for hernia repair
|
|
Infections and infestations
Infection- not otherwise specified
|
2.3%
4/173 • Number of events 4 • 1 year following surgery for hernia repair
|
5.1%
9/177 • Number of events 9 • 1 year following surgery for hernia repair
|
|
Vascular disorders
Pulmonary Embolism
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.56%
1/177 • Number of events 1 • 1 year following surgery for hernia repair
|
|
General disorders
Seroma
|
1.7%
3/173 • Number of events 3 • 1 year following surgery for hernia repair
|
4.0%
7/177 • Number of events 7 • 1 year following surgery for hernia repair
|
|
Infections and infestations
Surgical Site Infection
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
1.1%
2/177 • Number of events 2 • 1 year following surgery for hernia repair
|
|
Infections and infestations
Urinary Tract Infection
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
2.3%
4/177 • Number of events 4 • 1 year following surgery for hernia repair
|
|
General disorders
Wound Dehiscence
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
2.3%
4/177 • Number of events 4 • 1 year following surgery for hernia repair
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.58%
1/173 • Number of events 1 • 1 year following surgery for hernia repair
|
0.00%
0/177 • 1 year following surgery for hernia repair
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place