Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE cohort)

Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)

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.

Study Overview

• Status: Unknown
• Conditions: Hernia of Abdominal Wall; Biologic Mesh; Strattice
• Intervention / Treatment: Procedure: Complex abdominal wall repair Strattice

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Trauma Hospital Berlin
  • Frankfurt am Main, Germany
    • Johann Wolfgang Goethe-University
  • Hannover, Germany
    • Diakoniekrankenhaus Friederikenstiftung
  • Hausham, Germany
    • Agatharied Hospital
  • München, Germany
    • Klinikum rechts der Isar, Technical University of Munich
  • Wiesbaden, Germany
    • St. Josefs-Hospital Wiesbaden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients operated by members of the ROKI group (Arbeitsgruppe für Rekonstruktion komplexer Inzisionaler Hernien); i.e. a group of German hernia surgeons using Strattice for complex abdominal wall surgery. This group of surgeons is willing to share their patient cases with the investigators to achieve more knowledge on this delicate topic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Complex abdominal wall repair Strattice	Procedure: Complex abdominal wall repair Strattice; Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice); Other Names: Strattice; Porcine accelular dermal matrix; Non-cross-linked biologic mesh

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Johann Wolfgang Goethe University Hospital; Technical University of Munich; St. Josefs-Hospital Wiesbaden GmbH; Unfallkrankenhaus Berlin; Diakoniekrankenhaus Friederikenstift; Krankenhaus Agatharied Hausham
• Investigators: Principal Investigator: Ruth Kaufmann, MD, Erasmus Medical Center

Publications and helpful links

General Publications

• Kaufmann R, Isemer FE, Strey CW, Jeekel J, Lange JF, Woeste G. Non-cross-linked biological mesh in complex abdominal wall hernia: a cohort study. Langenbecks Arch Surg. 2020 May;405(3):345-352. doi: 10.1007/s00423-020-01881-4. Epub 2020 Apr 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 4, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Strattice; Biologic mesh; Complex abdominal wall hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: BASE cohort study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO