Clinical Trial: Abdominal Wall Repair With Strattice in Germany: a Cohort Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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

Detailed Summary:
Sponsor: Erasmus Medical Center

Current Primary Outcome:

• 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.
• Postoperative complications [ Time Frame: Postoperatively, until one year after initial operation ]
  All postoperative complications and their treatment will be registered.
• Survival [ Time Frame: Postoperatively; until three years after initial operation ]
  Any decease postoperatively

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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).
• Mesh explantations [ Time Frame: Postoperatively; until three years after initial operation ]
  Strattice mesh explantation after operation
• 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
• 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.)
• Quality of Life [ Time Frame: Postoperatively; measured at one, two and three years after initial operation ]
  Measured with questionnaires (SF-36, EQ-5D-5L, BIQ)
• Health economic analysis [ Time Frame: Postoperatively; until one year after initial operation ]
  Various cost-related parameters
• 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.

Original Secondary Outcome: Same as current

Information By: Erasmus Medical Center

Dates:
Date Received: June 12, 2014
Date Started: February 1, 2017
Date Completion: December 31, 2017
Last Updated: April 5, 2017
Last Verified: April 2017