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

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ClinicalTrials.gov Identifier: NCT02168231
Recruitment Status : Unknown
Verified August 2018 by Ruth Kaufmann, MD, Erasmus Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 20, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Unfallkrankenhaus Berlin
Johann Wolfgang Goethe University Hospital
Diakoniekrankenhaus Friederikenstift
Krankenhaus Agatharied Hausham
Technische Universität München
St. Josefs-Hospital Wiesbaden GmbH
Information provided by (Responsible Party):
Ruth Kaufmann, MD, 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.


Condition or disease Intervention/treatment
Hernia of Abdominal Wall Biologic Mesh Strattice Procedure: Complex abdominal wall repair Strattice

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
Complex abdominal wall repair Strattice
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




Primary Outcome Measures :
  1. Incisional hernia recurrence [ Time Frame: At one year after initial operation ]
    This parameter will be assessed by taking a history of the patient, and performing physical examination.

  2. Postoperative complications [ Time Frame: Postoperatively, until one year after initial operation ]
    All postoperative complications and their treatment will be registered.

  3. Survival [ Time Frame: Postoperatively; until three years after initial operation ]
    Any decease postoperatively


Secondary Outcome Measures :
  1. EHS incisional hernia classification [ Time Frame: 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).

  2. Mesh explantations [ Time Frame: Postoperatively; until three years after initial operation ]
    Strattice mesh explantation after operation

  3. Additional "abdominal wall repair" operations [ Time Frame: Postoperatively; until three years after initial operation ]
    Additional "abdominal wall (hernia) repair" operations after initial implantation of Strattice

  4. Indication of Strattice usage [ Time Frame: Perioperatively (noted just before or just after operation) ]
    Defined as preoperative conditions that influenced the decision (for instance: presence of stoma, fistulas, abscesses, etc.)

  5. Quality of Life (questionnaire-based) [ Time Frame: Postoperatively; measured at one, two and three years after initial operation ]
    Measured with questionnaires (SF-36, EQ-5D-5L, BIQ)

  6. Health economic analysis [ Time Frame: Postoperatively; until one year after initial operation ]
    Various cost-related parameters

  7. Incisional hernia recurrence [ Time Frame: At two and three years after initial operation ]
    This parameter will be assessed by taking a history of the patient, and performing physical examination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168231


Locations
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Germany
Trauma Hospital Berlin
Berlin, Germany
Johann Wolfgang Goethe-University
Frankfurt am Main, Germany
Diakoniekrankenhaus Friederikenstiftung
Hannover, Germany
Agatharied Hospital
Hausham, Germany
Klinikum rechts der Isar, Technical University of Munich
München, Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, Germany
Sponsors and Collaborators
Erasmus Medical Center
Unfallkrankenhaus Berlin
Johann Wolfgang Goethe University Hospital
Diakoniekrankenhaus Friederikenstift
Krankenhaus Agatharied Hausham
Technische Universität München
St. Josefs-Hospital Wiesbaden GmbH
Investigators
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Principal Investigator: Ruth Kaufmann, MD Erasmus Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ruth Kaufmann, MD, PhD fellow, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02168231    
Other Study ID Numbers: BASE cohort study
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ruth Kaufmann, MD, Erasmus Medical Center:
Complex abdominal wall hernia
Biologic mesh
Strattice
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical