Clinical Trial: The Permacol Dutch Cohort Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Permacol Dutch Cohort Study

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

Detailed Summary:
Sponsor: Erasmus Medical Center

Current Primary Outcome: Incisional Hernia recurrence [ Time Frame: One and two year after initial operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mesh explantations [ Time Frame: Anytime after abdominal wall reconstruction with Permacol until two years after operation ]
  This parameter will be assessed by taking a history of the patient and assessing operation room reports.
• Postoperative complications [ Time Frame: All postoperative complications are assessed until two years after initial operation ]
  This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.
• Additional "abdominal wall repair" operations [ Time Frame: After initial abdominal wall reconstruction with Permacol until two years after initial operation ]
  This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.
• Indication of Permacol usage [ Time Frame: Perioperatively ]
  The indication for usage of Permacol was noted just before or just after operation.
• Quality of Life [ Time Frame: A year or longer after initial abdominal wall reconstruction until two years after initial operation ]
  This parameter will be assessed various questionnaires (ShortForm-36, EuroQOL (EQ-5D-5L), and Body Image Questionnaire).

Original Secondary Outcome: Same as current

Information By: Erasmus Medical Center

Dates:
Date Received: June 10, 2014
Date Started: April 2013
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017