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

Not Applicable

Terminated

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: Ultrapro® Mesh implantation; Other: Standard wound closure

• Registration Number: NCT01189708
• Lead Sponsor: Cantonal Hospital of St. Gallen

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 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.

Study Timeline

• Study First Submitted: 2008-02-20
• Study Start: 2008-03
• Primary Completion: 2009-04
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Study Completion: 2011-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh implantation	Ultrapro® Mesh implantation	Ultrapro® Mesh implantation
Standard wound closure without a mesh	Standard wound closure	Standard wound closure

Primary Outcome Measures

Name	Time	Method
Incidence of incisional hernia	24 months

Secondary Outcome Measures

Name	Time	Method
operation time	4 hours
Rate of adverse events	24 months	Adverse events related to mesh implantation
Rate of postoperative complications	7 days

Trial Locations

Locations (1)

Kantonsspital St. Gallen, Department of Surgery; 🇨🇭 St. Gallen, Saint Gallen, Switzerland