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Trial record 4 of 143 for:    "Abdominal aortic aneurysm"
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Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

This study has been terminated.
(Treatment without success, low enrollment, one serious adverse event)
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01189708
First received: February 20, 2008
Last updated: August 26, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm
 Device: Ultrapro® Mesh implantation
Other: Standard wound closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Incidence of incisional hernia [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • operation time [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse events related to mesh implantation


Enrollment: 9
Study Start Date: March 2008
Estimated Study Completion Date: April 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189708

Locations
Switzerland
Kantonsspital St. Gallen, Department of Surgery
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Wolfgang Nagel, MD KSSG
  More Information

Additional Information:
Homepage of the Department of Surgery, Cantonal Hospital St. Gallen (KSSG)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Daniel Germann, Cantonal Hospital St. Gallen
ClinicalTrials.gov Identifier: NCT01189708     History of Changes
Other Study ID Numbers: EKSG08/006
Study First Received: February 20, 2008
Last Updated: August 26, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
Abdominal aortic aneurysm
Abdominal hernia

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Hernia
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013