Abdominal Wall Defects
Conditions
Keywords
Repair of patients' abdominal wall defects
Brief summary
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
Interventions
DEVICEPermacol Surgical Implant
Permacol Surgical Implant
Sponsors
Medtronic - MITG
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Equal or over 18 years of age * Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant. * At least 12 months of follow-up post date of surgery (-30 days) * Undergone open or laparoscopic repairs
Exclusion criteria
* Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair * Any prior use of Permacol in abdominal wall repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed Hernia Recurrence | 12 months | Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Unconfirmed Hernia or Hernia Recurrence | 12 Months | Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage) Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review |
| Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 2 to Year 8 | Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Permacol Patients Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up. | 343 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not eligible per protocol | 82 |
Baseline characteristics
| Characteristic | Permacol Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 107 Participants |
| Age, Categorical Between 18 and 65 years | 236 Participants |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 14 |
| Region of Enrollment Europe | 109 participants |
| Region of Enrollment United States | 234 participants |
| Sex: Female, Male Female | 162 Participants |
| Sex: Female, Male Male | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Confirmed Hernia Recurrence
Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Permacol Patients | Confirmed Hernia Recurrence | 20 participants |
Secondary
Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed
Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed
Time frame: Year 2 to Year 8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 2- out of 320 pts | 26 participants |
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 3- out of 133 pts | 19 participants |
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 4- out of 67 pts | 5 participants |
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 5- out of 25 pts | 4 participants |
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 6- out of 13 pts | 1 participants |
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 7- out of 6 pts | 1 participants |
| Permacol Patients | Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed | Year 8- out of 2 pts | 0 participants |
Secondary
Total Unconfirmed Hernia or Hernia Recurrence
Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage) Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Permacol Patients | Total Unconfirmed Hernia or Hernia Recurrence | 9 participants |