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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01214252
First received: September 30, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Abdominal Wall Defects
 Device: Permacol Surgical Implant

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Confirmed Hernia Recurrence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair siste. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon

  • Confirmed and Unconfirmed Hernias/Hernia Recurrences [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Unconfirmed Hernia or Hernia Recurrence [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Unconfirmed 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 reported by the patient is defined by confirmation of heria symptoms based on the Symptoms Questionnaire, but not confirmed by clinical assessment by surgeon.


Enrollment: 427
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Permacol Patients
Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
 Device: Permacol Surgical Implant
Permacol Surgical Implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone surgical repair of their abdominal wall defects with Permacol Surgical Implants with at least 12 months(-30days)follow-up

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214252

Locations
United States, Massachusetts
Annie Choi
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01214252     History of Changes
Other Study ID Numbers: COVPERH0046
Study First Received: September 30, 2010
Results First Received: June 21, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency
National Competent Authorities (NCAs) of EU Member states: UK

Keywords provided by Covidien:
Repair of patients' abdominal wall defects

ClinicalTrials.gov processed this record on May 21, 2013