An observational study in Hernia of Abdominal Wall, Biologic Implant and Infected Hernioplasty Mesh, sponsored by Erasmus Medical Center. Completed at 24 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by Erasmus Medical Center · Observational
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 77 is below the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The design of the trial will be a cross sectional cohort study. We will be gathering information from all the centers in the Netherlands who have used the Permacol© mesh in the past to treat complicated abdominal wall defects. Patients will be asked to return to the hospitals outpatient clinic. A total of around 70 patients will be included into the study.
Exclusion Criteria:
No intervention performed
Procedure: Permacol mesh placement
All patients were treated for a complex abdominal wall hernia by implantation of Permacol mesh. This intervention took place before patients were included in the cohort.
Incisional Hernia recurrence
This parameter will be assessed by taking a history of the patient and assessing operation room reports.
Time frame: One and two year after initial operation
Mesh explantations
This parameter will be assessed by taking a history of the patient and assessing operation room reports.
Time frame: Anytime after abdominal wall reconstruction with Permacol until two years after operation
Postoperative complications
This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.
Time frame: All postoperative complications are assessed until two years after initial operation
Additional "abdominal wall repair" operations
This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.
Time frame: After initial abdominal wall reconstruction with Permacol until two years after initial operation
Indication of Permacol usage
The indication for usage of Permacol was noted just before or just after operation.
Time frame: Perioperatively
Quality of Life
This parameter will be assessed various questionnaires (ShortForm-36, EuroQOL (EQ-5D-5L), and Body Image Questionnaire).
Time frame: A year or longer after initial abdominal wall reconstruction until two years after initial operation
Plan to share: No
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Erasmus Medical Center