Clinical Trial: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair

Brief Summary:

The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved.

Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.


Detailed Summary:

Prospective randomized controlled study with two study arms.

Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair.

Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation)

After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list.

Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period.

Study enrollment was prematurely terminated on 30. Apr 2009. Already enrolled patients will be followed for 24 months according to protocol.


Sponsor: Cantonal Hospital of St. Gallen

Current Primary Outcome: Incidence of incisional hernia [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of postoperative complications [ Time Frame: 7 days ]
  • operation time [ Time Frame: 4 hours ]
  • Rate of adverse events [ Time Frame: 24 months ]
    Adverse events related to mesh implantation


Original Secondary Outcome:

  • Postoperative complications [ Time Frame: 7 days ]
  • operation time [ Time Frame: 4 hours ]
  • Adverse events [ Time Frame: 24 months ]
    Adverse events related to mesh implantation


Information By: Cantonal Hospital of St. Gallen

Dates:
Date Received: February 20, 2008
Date Started: March 2008
Date Completion:
Last Updated: July 9, 2015
Last Verified: July 2015