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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 20, 2008
First Posted Date  ICMJE August 27, 2010
Last Update Posted Date July 10, 2015
Study Start Date  ICMJE March 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
Incidence of incisional hernia [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2015)
  • Rate of postoperative complications [ Time Frame: 7 days ]
  • operation time [ Time Frame: 4 hours ]
  • Rate of adverse events [ Time Frame: 24 months ]
    Adverse events related to mesh implantation
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2010)
  • Postoperative complications [ Time Frame: 7 days ]
  • operation time [ Time Frame: 4 hours ]
  • Adverse events [ Time Frame: 24 months ]
    Adverse events related to mesh implantation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair
Official Title  ICMJE Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Abdominal Aortic Aneurysm
Intervention  ICMJE
  • 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.
  • Other: Standard wound closure
    Abdominal closure will be performed with standard sutures without a mesh.
Study Arms  ICMJE
  • Experimental: Mesh implantation
    Ultrapro® Mesh implantation
    Intervention: Device: Ultrapro® Mesh implantation
  • Active Comparator: Standard wound closure without a mesh
    Standard wound closure
    Intervention: Other: Standard wound closure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 26, 2010)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189708
Other Study ID Numbers  ICMJE EKSG08/006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrich Beutner, Cantonal Hospital of St. Gallen
Study Sponsor  ICMJE Cantonal Hospital of St. Gallen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wolfgang Nagel, MD KSSG
PRS Account Cantonal Hospital of St. Gallen
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP