Abdominal Wall Repair With Strattice in Germany: a Cohort Study

Hernia of Abdominal Wall Clinical Trial

— BASE cohort  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02168231
• Other study ID #: BASE cohort study
• Status: Enrolling by invitation
• Start date: February 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2018
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biologic Mesh
• Hernia
• Hernia of Abdominal Wall
• Hernia, Abdominal
• Strattice

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (7)

Lead Sponsor	Collaborator
Erasmus Medical Center	Diakoniekrankenhaus Friederikenstift, Johann Wolfgang Goethe University Hospital, Krankenhaus Agatharied Hausham, St. Josefs-Hospital Wiesbaden, Technische Universität München, Unfallkrankenhaus Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Postoperative complications	All postoperative complications and their treatment will be registered.	Postoperatively, until one year after initial operation
Primary	Survival	Any decease postoperatively	Postoperatively; until three years after initial operation
Secondary	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)
Secondary	Mesh explantations	Strattice mesh explantation after operation	Postoperatively; until three years after initial operation
Secondary	Additional "abdominal wall repair" operations	Additional "abdominal wall (hernia) repair" operations after initial implantation of Strattice	Postoperatively; until three years after initial operation
Secondary	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)
Secondary	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
Secondary	Health economic analysis	Various cost-related parameters	Postoperatively; until one year after initial operation
Secondary	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