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Clinical Trials/NCT02166112
NCT02166112
Completed
Not Applicable

The Permacol Dutch Cohort Study

Erasmus Medical Center24 sites in 1 country77 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hernia of Abdominal Wall
Sponsor
Erasmus Medical Center
Enrollment
77
Locations
24
Primary Endpoint
Incisional Hernia recurrence
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented.

In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.

The aim of this study is investigate the short and long term effects of the Permacol© biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ruth Kaufmann, MD

PhD fellow

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent
  • Complicated abdominal wall hernia repair
  • Permacol© mesh implantation

Exclusion Criteria

  • No signed informed consent
  • Operation other than Complicated abdominal wall hernia repair
  • Implant other than Permacol© mesh implantation

Outcomes

Primary Outcomes

Incisional Hernia recurrence

Time Frame: One and two year after initial operation

This parameter will be assessed by taking a history of the patient and assessing operation room reports.

Secondary Outcomes

  • Quality of Life(A year or longer after initial abdominal wall reconstruction until two years after initial operation)
  • Postoperative complications(All postoperative complications are assessed until two years after initial operation)
  • Indication of Permacol usage(Perioperatively)
  • Mesh explantations(Anytime after abdominal wall reconstruction with Permacol until two years after operation)
  • Additional "abdominal wall repair" operations(After initial abdominal wall reconstruction with Permacol until two years after initial operation)

Study Sites (24)

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