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

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ClinicalTrials.gov Identifier: NCT01189708
Recruitment Status : Terminated (Treatment without success, low enrollment, one serious adverse event)
First Posted : August 27, 2010
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Ulrich Beutner, Cantonal Hospital of St. Gallen

Study Description
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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.


Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: Ultrapro® Mesh implantation Other: Standard wound closure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of incisional hernia [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Rate of postoperative complications [ Time Frame: 7 days ]
  2. operation time [ Time Frame: 4 hours ]
  3. Rate of adverse events [ Time Frame: 24 months ]
    Adverse events related to mesh implantation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189708


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

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Responsible Party: Ulrich Beutner, Research Manager, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01189708    
Other Study ID Numbers: EKSG08/006
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015
Keywords provided by Ulrich Beutner, Cantonal Hospital of St. Gallen:
Abdominal aortic aneurysm
Abdominal hernia
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Complications
Pathologic Processes