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

Completed

• Conditions: Abdominal Wall Defects
• Interventions: Device: Permacol Surgical Implant

• Registration Number: NCT01214252
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-30
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-05
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Results First Submitted: 2012-06-21
• Results First Submitted QC: 2012-12-19
• Results First Posted: 2012-12-20
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Permacol Patients	Permacol Surgical Implant	Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Annie Choi; 🇺🇸 Bedford, Massachusetts, United States