Abdominal Wall Repair With Strattice in Germany: a Cohort Study

• Conditions: Hernia of Abdominal Wall; Biologic Mesh; Strattice
• Interventions: Procedure: Complex abdominal wall repair Strattice

• Registration Number: NCT02168231
• 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 to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-20
• Study Start: 2017-02-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-04
• Last Update Posted: 2018-08-07
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age of 18 years or older
• Signed informed consent
• Abdominal wall repair
• Strattice mesh implantation prior to inclusion in BASE cohort

Exclusion Criteria

• Age under 18 years
• No signed informed consent
• Other operation than abdominal wall repair
• Other mesh than Strattice mesh

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complex abdominal wall repair Strattice	Complex abdominal wall repair Strattice	Complex abdominal wall repair Strattice

Primary Outcome Measures

Name	Time	Method
Incisional hernia recurrence	At one year after initial operation	This parameter will be assessed by taking a history of the patient, and performing physical examination.
Postoperative complications	Postoperatively, until one year after initial operation	All postoperative complications and their treatment will be registered.
Survival	Postoperatively; until three years after initial operation	Any decease postoperatively

Secondary Outcome Measures

Name	Time	Method
Mesh explantations	Postoperatively; until three years after initial operation	Strattice mesh explantation after operation
Incisional hernia recurrence	At two and three years after initial operation	This parameter will be assessed by taking a history of the patient, and performing physical examination.
Health economic analysis	Postoperatively; until one year after initial operation	Various cost-related parameters
EHS incisional hernia classification	Perioperatively (noted just before or just after operation)	Classification according to Ventral Hernia Working Group classification (Breuing et al. Surgery 2010; 148(3): 544-58).
Additional "abdominal wall repair" operations	Postoperatively; until three years after initial operation	Additional "abdominal wall (hernia) repair" operations after initial implantation of Strattice
Indication of Strattice usage	Perioperatively (noted just before or just after operation)	Defined as preoperative conditions that influenced the decision (for instance: presence of stoma, fistulas, abscesses, etc.)
Quality of Life (questionnaire-based)	Postoperatively; measured at one, two and three years after initial operation	Measured with questionnaires (SF-36, EQ-5D-5L, BIQ)

Trial Locations

Locations (6)

Diakoniekrankenhaus Friederikenstiftung; 🇩🇪 Hannover, Germany

Trauma Hospital Berlin; 🇩🇪 Berlin, Germany

Johann Wolfgang Goethe-University; 🇩🇪 Frankfurt am Main, Germany

Agatharied Hospital; 🇩🇪 Hausham, Germany

Klinikum rechts der Isar, Technical University of Munich; 🇩🇪 München, Germany

St. Josefs-Hospital Wiesbaden; 🇩🇪 Wiesbaden, Germany