Trial Outcomes & Findings for Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch (NCT NCT00866814)
NCT ID: NCT00866814
Last Updated: 2012-10-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
119 participants
Primary outcome timeframe
1 year post surgery
Results posted on
2012-10-12
Participant Flow
From March 2009 through May 2010, a total of 119 patients were enrolled at 7 study centers in the United States.
Participant milestones
| Measure |
Ventrio Group
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Ventrio Group
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
No longer wished to participate
|
1
|
|
Overall Study
Unable to meet follow-up requirements
|
2
|
|
Overall Study
Moved to area without study site
|
1
|
Baseline Characteristics
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
Baseline characteristics by cohort
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
Age Continuous
|
55.8 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
|
Body Mass Index
|
33.5 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post surgeryPopulation: All enrolled 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.
Outcome measures
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
|
0 participants
|
SECONDARY outcome
Timeframe: From the time of surgery to hospital discharge, an average of 1-2 daysPopulation: All enrolled patients.
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.
Outcome measures
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
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 outcome
Timeframe: Hospital discharge through 21 days post surgeryPopulation: All enrolled patients.
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.
Outcome measures
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: 22 days post surgery through 1 year post surgeryPopulation: All enrolled patients.
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.
Outcome measures
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
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 outcome
Timeframe: Baseline and post-surgery at week 2, month 6 and month 12Population: All enrolled patients with QOL scores at each visit.
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.
Outcome measures
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: All enrolled patients.
Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.
Outcome measures
| Measure |
Ventrio Group
n=119 Participants
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
Procedure Time
|
42.8 minutes
Standard Deviation 19.8
|
Adverse Events
Ventrio Group
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ventrio Group
n=119 participants at risk
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
Gastrointestinal disorders
Consitpation
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Infections and infestations
Abdominal abscess
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Infections and infestations
Postoperative wound infection
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Infections and infestations
Wound infection
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer recurrent
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
Other adverse events
| Measure |
Ventrio Group
n=119 participants at risk
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Gastrointestinal disorders
Nausea
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Gastrointestinal disorders
Vomiting
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
General disorders
Application site vesicles
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
General disorders
Hernia
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Injury, poisoning and procedural complications
Seroma
|
4.2%
5/119 • Number of events 5 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Nervous system disorders
Hypoaesthesia
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Renal and urinary disorders
Urinary retention
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
|
Vascular disorders
Haematoma
|
0.84%
1/119 • Number of events 1 • Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.
Adverse events were defined as any undesirable clinical event occurring in the abdominal wall or involving abdominal organs and/or judged to be related to the surgical procedure or Ventrio hernia patch.
|
Additional Information
Dawn Heimer/Director, Clinical Affairs
C.R. Bard: Davol, Inc.
Phone: 401-825-8681
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60