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

September 15, 2023 updated by: Ignazio Tarantino, Cantonal Hospital of St. Gallen

Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Saint Gallen
      • St. Gallen, Saint Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesh implantation
Ultrapro® Mesh implantation
Device: Ultrapro® Mesh implantation
After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.
Active Comparator: Standard wound closure without a mesh
Standard wound closure
Other: Standard wound closure
Abdominal closure will be performed with standard sutures without a mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of incisional hernia
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative complications
Time Frame: 7 days
7 days
operation time
Time Frame: 4 hours
4 hours
Rate of adverse events
Time Frame: 24 months
Adverse events related to mesh implantation
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Wolfgang Nagel, MD, KSSG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimated)

August 27, 2010

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKSG08/006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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