Abdominal Wall Repair With Strattice in Germany: a Cohort Study

NCT02168231 | Unknown

• 1 other identifier: BASE cohort study
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 6

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.

Conditions

Hernia of Abdominal Wall; Biologic Mesh; Strattice

Keywords

Complex abdominal wall hernia; Biologic mesh; Strattice

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• EHS incisional hernia classification

  Perioperatively (noted just before or just after operation)

• Mesh explantations

  Postoperatively; until three years after initial operation

• Additional "abdominal wall repair" operations

  Postoperatively; until three years after initial operation

• Indication of Strattice usage

  Perioperatively (noted just before or just after operation)

• Quality of Life (questionnaire-based)

  Postoperatively; measured at one, two and three years after initial operation

Study Arms (1)

Complex abdominal wall repair Strattice

Complex abdominal wall repair Strattice

Procedure: Complex abdominal wall repair Strattice

Interventions

Complex abdominal wall repair Strattice PROCEDURE

Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)

Also known as: Strattice, Porcine accelular dermal matrix, Non-cross-linked biologic mesh

Complex abdominal wall repair Strattice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age of 18 years or older
• Signed informed consent
• Abdominal wall repair

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Unfallkrankenhaus Berlin: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• Diakoniekrankenhaus Friederikenstift: collaborator
• Krankenhaus Agatharied Hausham: collaborator
• Technical University of Munich: collaborator
• St. Josefs-Hospital Wiesbaden GmbH: collaborator

Study Sites (6)

Trauma Hospital Berlin

Berlin, Germany

Location

Johann Wolfgang Goethe-University

Frankfurt am Main, Germany

Location

Diakoniekrankenhaus Friederikenstiftung

Hanover, Germany

Location

Agatharied Hospital

Hausham, Germany

Location

Klinikum rechts der Isar, Technical University of Munich

München, Germany

Location

St. Josefs-Hospital Wiesbaden

Wiesbaden, Germany

Location

Related Publications (1)

• 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.

  PMID: 32323007 DERIVED

MeSH Terms

Conditions

Hernia, Abdominal

Interventions

strattice

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruth Kaufmann, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 20, 2014
• Study Start: February 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)