An observational study in Ventral Hernia, sponsored by C. R. Bard. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-12.
Sponsored by C. R. Bard · Observational
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 119 is close to the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with a diagnosis of ventral hernia will be screened for eligibility against the study protocol inclusion and exclusion criteria utilizing standard preoperative criteria (e.g. physical examination, blood work, medical evaluation, etc) which occurred within 30 days of the date of consent.
Exclusion Criteria:
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
Device: Bard 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.
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
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
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
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
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
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
From March 2009 through May 2010, a total of 119 patients were enrolled at 7 study centers in the United States.
| Milestone | Ventrio Group |
|---|---|
| Started | 119 |
| Completed | 99 |
| Not completed | 20 |
| Withdrew: Lost to follow-up | 12 |
| Withdrew: Adverse event | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Death | 1 |
| Withdrew: No longer wished to participate | 1 |
| Withdrew: Unable to meet follow-up requirements | 2 |
| Withdrew: Moved to area without study site | 1 |
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.
| participants | Ventrio Group |
|---|---|
| The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. | 0 |
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.
| Complication events | 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 |
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.
| Complication events | 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 |
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.
| Complication events | 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 |
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.
| units on a scale (0-5) | Ventrio Group |
|---|---|
| Sensation of mesh: week 2 | 0.7 ± 1.2 |
| Sensation of mesh: month 6 | 0.3 ± 0.7 |
| Sensation of mesh: month 12 | 0.1 ± 0.5 |
| Pain: baseline | 1.3 ± 1.3 |
| Pain: week 2 | 1.6 ± 1.4 |
| Pain: month 6 | 0.3 ± 0.6 |
| Pain month 12 | 0.2 ± 0.6 |
| Movement limitations: baseline | 1.1 ± 1.3 |
| Movement limitations: week 2 | 1.4 ± 1.4 |
| Movement limitations: month 6 | 0.2 ± 0.6 |
| Movement limitation month 12 | 0.1 ± 0.5 |
Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.
| minutes | Ventrio Group |
|---|---|
| Procedure Time | 42.8 ± 19.8 |
Collected over Protocol defined adverse events were collected beginning at the time of the study repair procedure (first incision) through study completion or withdrawal.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ventrio Group | — | 8/119 (6.7%) | 14/119 (11.8%) |
| Event | Ventrio Group |
|---|---|
| ConsitpationGastrointestinal disorders | 1/119 |
| Gastric ulcerGastrointestinal disorders | 1/119 |
| Cholecystitis acuteHepatobiliary disorders | 1/119 |
| Hepatic failureHepatobiliary disorders | 1/119 |
| Abdominal abscessInfections and infestations | 1/119 |
| Postoperative wound infectionInfections and infestations | 1/119 |
| Wound infectionInfections and infestations | 1/119 |
| Postoperative ileusInjury, poisoning and procedural complications | 1/119 |
| SeromaInjury, poisoning and procedural complications | 1/119 |
| HypokalaemiaMetabolism and nutrition disorders | 1/119 |
| Event | Ventrio Group |
|---|---|
| SeromaInjury, poisoning and procedural complications | 5/119 |
| DiarrhoeaGastrointestinal disorders | 1/119 |
| Gastric ulcerGastrointestinal disorders | 1/119 |
| NauseaGastrointestinal disorders | 1/119 |
| OesophagitisGastrointestinal disorders | 1/119 |
| VomitingGastrointestinal disorders | 1/119 |
| Application site vesiclesGeneral disorders | 1/119 |
| HerniaGeneral disorders | 1/119 |
| Postoperative ileusInjury, poisoning and procedural complications | 1/119 |
| HypoaesthesiaNervous system disorders | 1/119 |
| Age Continuous(years) | Ventrio Group |
|---|---|
| Mean | 55.8 ± 13.6 |
| Sex: Female, Male(Participants) | Ventrio Group |
|---|---|
| Female | 71 |
| Male | 48 |
| Region of Enrollment(participants) | Ventrio Group |
|---|---|
| United States | 119 |
| Body Mass Index(kg/m^2) | Ventrio Group |
|---|---|
| Mean | 33.5 ± 7.1 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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C. R. Bard