N/A
N=425
A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
Abdominal Wall Defects
Bottom Line
View on ClinicalTrials.gov: NCT01214252 ↗Enrolled (actual)
425
Serious AEs
—
Results posted
Dec 2012
Primary outcome: Primary: Confirmed Hernia Recurrence — 20 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Permacol Surgical Implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Hernia Recurrence |
20 | — |
| SECONDARY Total Unconfirmed Hernia or Hernia Recurrence |
9 | — |
| SECONDARY Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed |
26; 19; 5; 4; 1; 1 | — |
Summary
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01214252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.