Clinical Trial: Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study

Brief Summary:

AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.

The primary objective of the clinical investigation is to test the hypothesis that insertion of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized, polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will reduce the hernia formation rate within the first 2 years.

A reduction from 30% to 10% of the patient population is assumed.


Detailed Summary:

One of the late complications of the elective surgery of an Abdominal Aortic Aneurysms (AAA) is the formation of an incisional hernia following the AAA repair.

The high frequency of incisional hernia formation in the AAA patients suggests the presence of a structural defect within the fascia.

As a result of these information and that obtained from a small pilot study using mesh prophylactically in high risk group of patients, the concept of using a mesh prophylactically for AAA repairs seems an area worth further exploration.

Owing to the availability of the new generation of meshes with proven good biocompatibility it would seem that this could be a viable means of reducing the herniation rate and therefore re-operation in this high risk population.

Within the investigation Patients requiring elective surgical repair of an AAA will be randomized in one of the following three different groups:

  • Group A: Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision.
  • Group B: Abdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures.
  • Group C: Monofilament, absorbable MonoMax® suture material will be used for the closure of the abdominal cavity.

A total of 282 patients who meet the eligibility criteria will be entered into the clinical investigation (Group A = 94 patients, Group B = 94 patients and Group C = 94 patients).

All patients wi
Sponsor: Universitätsklinikum Hamburg-Eppendorf

Current Primary Outcome: Herniation rate [ Time Frame: 24 months ]

As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.


Original Primary Outcome: Herniation rate [ Time Frame: 24 months ]

The reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universitätsklinikum Hamburg-Eppendorf

Dates:
Date Received: April 18, 2011
Date Started: February 2011
Date Completion: September 2015
Last Updated: November 18, 2014
Last Verified: November 2014