The Permacol Dutch Cohort Study

Completed

• Conditions: Hernia of Abdominal Wall; Biologic Implant; Infected Hernioplasty Mesh
• Interventions: Procedure: Permacol mesh placement

• Registration Number: NCT02166112
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2014-05
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Permacol mesh placement	Permacol mesh placement	No intervention performed

Primary Outcome Measures

Name	Time	Method
Incisional Hernia recurrence	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 Outcome Measures

Name	Time	Method
Postoperative complications	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.
Indication of Permacol usage	Perioperatively	The indication for usage of Permacol was noted just before or just after operation.
Quality of Life	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).
Mesh explantations	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.
Additional "abdominal wall repair" operations	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.

Trial Locations

Locations (24)

Meander MC; 🇳🇱 Amersfoort, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Lievensberg; 🇳🇱 Bergen op Zoom, Netherlands

Amphia; 🇳🇱 Breda, Netherlands

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Nij Smellinghe; 🇳🇱 Drachten, Netherlands

MC Haaglanden; 🇳🇱 Den Haag, Netherlands

Catharina; 🇳🇱 Eindhoven, Netherlands

Groene Hart; 🇳🇱 Gouda, Netherlands

UMC Groningen; 🇳🇱 Groningen, Netherlands

Atrium MC; 🇳🇱 Heerlen, Netherlands

Tergooi ziekenhuizen; 🇳🇱 Hilversum, Netherlands

Spaarne ziekenhuis; 🇳🇱 Hoofddorp, Netherlands

MC Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

MUMC+; 🇳🇱 Maastricht, Netherlands

Waterland; 🇳🇱 Purmerend, Netherlands

Franciscus; 🇳🇱 Roosendaal, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Havenziekenhuis; 🇳🇱 Rotterdam, Netherlands

Orbis MC; 🇳🇱 Sittard, Netherlands

TweeSteden; 🇳🇱 Tilburg, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

VieCuri; 🇳🇱 Venlo, Netherlands