Clinical trial NCT02168231: Abdominal Wall Repair With Strattice in Germany: a Cohort Study
Official title: Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hernia of Abdominal Wall
Biologic Mesh
Strattice
Keywords: Complex abdominal wall hernia
Biologic mesh
Strattice
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Unfallkrankenhaus Berlin
name: Johann Wolfgang Goethe University Hospital
name: Diakoniekrankenhaus Friederikenstift
name: Krankenhaus Agatharied Hausham
name: Technical University of Munich
name: St. Josefs-Hospital Wiesbaden GmbH
First posted: 2014-06-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incisional hernia recurrence
timeFrame: At one year after initial operation
measure: Postoperative complications
timeFrame: Postoperatively, until one year after initial operation
measure: Survival
timeFrame: Postoperatively; until three years after initial operation
Secondary outcomes:
measure: EHS incisional hernia classification
timeFrame: Perioperatively (noted just before or just after operation)
measure: Mesh explantations
timeFrame: Postoperatively; until three years after initial operation
measure: Additional "abdominal wall repair" operations
timeFrame: Postoperatively; until three years after initial operation
measure: Indication of Strattice usage
timeFrame: Perioperatively (noted just before or just after operation)
measure: Quality of Life (questionnaire-based)
timeFrame: Postoperatively; measured at one, two and three years after initial operation
measure: Health economic analysis
timeFrame: Postoperatively; until one year after initial operation
measure: Incisional hernia recurrence
timeFrame: At two and three years after initial operation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Trauma Hospital Berlin
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe-University
city: Hannover
country: Germany
facility: Diakoniekrankenhaus Friederikenstiftung
city: Hausham
country: Germany
facility: Agatharied Hospital
city: München
country: Germany
facility: Klinikum rechts der Isar, Technical University of Munich
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden
Study officials:
affiliation: Erasmus Medical Center
name: Ruth Kaufmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.