A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects

Medtronic - MITG343 enrolled

Overview

To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.

Study Type

OBSERVATIONAL

Enrollment

343

Conditions

Abdominal Wall Defects

Interventions

Permacol Surgical ImplantDEVICE

Permacol Surgical Implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Annie Choi

Bedford, Massachusetts, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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