Abdominal Wall Defects Clinical Trial
To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.
Status | Completed |
Enrollment | 343 |
Est. completion date | January 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Annie Choi | Bedford | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 12 months | Yes |
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 |
12 Months | Yes |
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 | Year 2 to Year 8 | Yes |