Ventral Hernia
Conditions
Keywords
hernia, open
Brief summary
This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.
Interventions
DEVICEBard Ventrio Hernia Patch
The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Sponsors
FGK Clinical Research GmbH
C. R. Bard
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, age ≥ 18 2. Be able to undergo study procedures 3. Have signed an Informed Consent form (ICF) 4. Be diagnosed with a ventral hernia requiring an open surgery for repair.
Exclusion criteria
1. Patient is participating in another device or drug study. 2. Patient exhibits clinical symptoms indicating infected hernia site. 3. Patient currently has a clean contaminated or contaminated site. 4. Patient has a life expectancy less than 2 years at the time of enrollment. 5. Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. | 1 year post surgery | A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. | From the time of surgery to hospital discharge, an average of 1-2 days | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. |
| Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. | Hospital discharge through 21 days post surgery | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. |
| Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. | 22 days post surgery through 1 year post surgery | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. |
| Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Baseline and post-surgery at week 2, month 6 and month 12 | Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure. |
| Procedure Time | Day of surgery | Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed. |
Countries
United States
Participant flow
Recruitment details
From March 2009 through May 2010, a total of 119 patients were enrolled at 7 study centers in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Ventrio Group Patients diagnosed with a ventral hernia requiring an open surgery for repair. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Moved to area without study site | 1 |
| Overall Study | No longer wished to participate | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Unable to meet follow-up requirements | 2 |
Baseline characteristics
| Characteristic | Ventrio Group |
|---|---|
| Age Continuous | 55.8 years STANDARD_DEVIATION 13.6 |
| Body Mass Index | 33.5 kg/m^2 STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 119 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 119 |
| serious Total, serious adverse events | 8 / 119 |
Outcome results
Primary
The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.
Time frame: 1 year post surgery
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventrio Group | The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. | 0 participants |
Secondary
Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.
In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Time frame: 22 days post surgery through 1 year post surgery
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventrio Group | Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. | 6 Complication events |
Secondary
Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.
In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Time frame: From the time of surgery to hospital discharge, an average of 1-2 days
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventrio Group | Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. | 4 Complication events |
Secondary
Procedure Time
Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.
Time frame: Day of surgery
Population: All enrolled patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventrio Group | Procedure Time | 42.8 minutes | Standard Deviation 19.8 |
Secondary
Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey
Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure.
Time frame: Baseline and post-surgery at week 2, month 6 and month 12
Population: All enrolled patients with QOL scores at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Sensation of mesh: week 2 | 0.7 units on a scale (0-5) | Standard Deviation 1.2 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Sensation of mesh: month 6 | 0.3 units on a scale (0-5) | Standard Deviation 0.7 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Sensation of mesh: month 12 | 0.1 units on a scale (0-5) | Standard Deviation 0.5 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Pain: baseline | 1.3 units on a scale (0-5) | Standard Deviation 1.3 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Pain: week 2 | 1.6 units on a scale (0-5) | Standard Deviation 1.4 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Pain: month 6 | 0.3 units on a scale (0-5) | Standard Deviation 0.6 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Movement limitation month 12 | 0.1 units on a scale (0-5) | Standard Deviation 0.5 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Pain month 12 | 0.2 units on a scale (0-5) | Standard Deviation 0.6 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Movement limitations: baseline | 1.1 units on a scale (0-5) | Standard Deviation 1.3 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Movement limitations: week 2 | 1.4 units on a scale (0-5) | Standard Deviation 1.4 |
| Ventrio Group | Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey | Movement limitations: month 6 | 0.2 units on a scale (0-5) | Standard Deviation 0.6 |
Secondary
Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.
In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.
Time frame: Hospital discharge through 21 days post surgery
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventrio Group | Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. | 10 Complication events |