Hernia
Conditions
Brief summary
This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
Interventions
None listed
Sponsors
C. R. Bard
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study. * Have signed an Informed Consent Form (ICF).
Exclusion criteria
* Underwent implantation of Sepramesh for any reason other than ventral hernia repair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) | A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications in Subjects With Hernias Repaired With Sepramesh. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) | Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination). |
| Procedural Time for Sepramesh Placement. | Day 0 | Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin). |
| Recovery Time Associated With Hernias Repaired With Sepramesh. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) | Recovery time will be defined as the time it took for the subject to return to work. |
Countries
United States
Participant flow
Recruitment details
Between October 2010 and February 2011, a total of 90 subjects were enrolled at a single study site.
Participants by arm
| Arm | Count |
|---|---|
| Sepramesh Group Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment. | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Sepramesh Group |
|---|---|
| Age Continuous | 56.0 years STANDARD_DEVIATION 12.23 |
| Body Mass Index | 33.9 kilograms per square meter STANDARD_DEVIATION 7.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 170.3 centimeters STANDARD_DEVIATION 10.16 |
| Hernia Classification Incisional | 42 participants |
| Hernia Classification Umbilical | 43 participants |
| Hernia Classification Umbilical and Incisional | 5 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment United States | 90 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 48 Participants |
| Weight | 98.5 kilograms STANDARD_DEVIATION 23.92 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 90 |
| serious Total, serious adverse events | 3 / 90 |
Outcome results
Primary
Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.
A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.
Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Population: All enrolled subjects were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sepramesh Group | Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. | 1 participants |
Secondary
Complications in Subjects With Hernias Repaired With Sepramesh.
Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).
Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Population: All enrolled subjects were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sepramesh Group | Complications in Subjects With Hernias Repaired With Sepramesh. | 2 participants |
Secondary
Procedural Time for Sepramesh Placement.
Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).
Time frame: Day 0
Population: All enrolled subjects were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sepramesh Group | Procedural Time for Sepramesh Placement. | 41.4 minutes | Standard Deviation 20.56 |
Secondary
Recovery Time Associated With Hernias Repaired With Sepramesh.
Recovery time will be defined as the time it took for the subject to return to work.
Time frame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Population: Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed.
Post Hoc
Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh.
A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure.
Time frame: 12 months or greater
Population: The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sepramesh Group | Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh. | 1 participants |
Post Hoc
Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh.
A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure.
Time frame: 12 months or greater
Population: The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sepramesh Group | Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh. | 0 participants |
Post Hoc
Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias
A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.
Time frame: 12 months or greater
Population: This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sepramesh Group | Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias | 0 participants |