The Permacol Dutch Cohort Study

Hernia of Abdominal Wall Clinical Trial

Official title:

The Permacol Dutch Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166112
• Other study ID #: Permacol Dutch Cohort Study
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: April 5, 2017
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2017
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biologic Implant
• Hernia
• Hernia of Abdominal Wall
• Hernia, Abdominal
• Infected Hernioplasty Mesh

Intervention

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.

Locations

Country	Name	City	State
Netherlands	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	MC Haaglanden	Den Haag
Netherlands	Nij Smellinghe	Drachten
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

Sponsors (24)

Lead Sponsor

Collaborator

Erasmus Medical Center

Amphia, Breda, the Netherlands, Catharina Ziekenhuis Eindhoven, Franciscus, Roosendaal, the Netherlands, Groene Hart, Gouda, the Netherlands, Havenziekenhuis, Rotterdam, the Netherlands, Lievensberg, Bergen op Zoom, the Netherlands, MC Leeuwarden, Leeuwarden, the Netherlands, Meander MC, Amersfoort, the Netherlands, Medical Center Haaglanden, MUMC+, Maastricht, the Netherlands, Nij Smellinghe, Drachten, the Netherlands, OLVG, Amsterdam, the Netherlands, Orbis MC, Sittard, the Netherlands, Reinier de Graaf gasthuis, Delft, the Netherlands, Rijnstate, Arnhem, the Netherlands, Spaarne ziekenhuis, Hoofddorp, the Netherlands, Tergooi ziekenhuizen, Hilversum, the Netherlands, The Elisabeth-TweeSteden Hospital, UMC Groningen, Groningen, the Netherlands, UMC Utrecht, Utrecht, the Netherlands, VieCuri, Venlo, the Netherlands, Waterland, Purmerend, the Netherlands, Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional Hernia recurrence	This parameter will be assessed by taking a history of the patient and assessing operation room reports.	One and two year after initial operation
Secondary	Mesh explantations	This parameter will be assessed by taking a history of the patient and assessing operation room reports.	Anytime after abdominal wall reconstruction with Permacol until two years after operation
Secondary	Postoperative complications	This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.	All postoperative complications are assessed until two years after initial operation
Secondary	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.	After initial abdominal wall reconstruction with Permacol until two years after initial operation
Secondary	Indication of Permacol usage	The indication for usage of Permacol was noted just before or just after operation.	Perioperatively
Secondary	Quality of Life	This parameter will be assessed various questionnaires (ShortForm-36, EuroQOL (EQ-5D-5L), and Body Image Questionnaire).	A year or longer after initial abdominal wall reconstruction until two years after initial operation