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

Cantonal Hospital of St. Gallen

Status: Terminated

Conditions: Abdominal Aortic Aneurysm

Treatments: Other: Standard wound closure; Device: Ultrapro® Mesh implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01189708

EKSG08/006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient scheduled for elective or early elective open repair of aortic aneurysm

Exclusion criteria

• Emergency surgery
• EVAR (endovascular procedure)
• Patients with previous midline laparotomy
• Patients with in situ abdominal mesh after previous hernia repair
• Patients with large diastasis of abdominal wall
• Allergy to penicillin
• Women before menopause (mesh can interfere with potential future pregnancies)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Mesh implantation

Experimental group

Description:

Ultrapro® Mesh implantation

Treatment:

Device: Ultrapro® Mesh implantation

Standard wound closure without a mesh

Active Comparator group

Description:

Standard wound closure

Treatment:

Other: Standard wound closure