Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment (PRIMAAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00757133
First received: September 18, 2008
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.


Condition Intervention
Aortic Aneurysm
Procedure: Conventional laparotomy closure
Procedure: Laparotomy closure with mesh augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • To reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy Incidence of incisonal hernia [ Time Frame: 2 years postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of incisonal hernia [ Time Frame: 1 year and 5 years after surgery ] [ Designated as safety issue: Yes ]
  • VAS scores of pain at rest [ Time Frame: 12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery ] [ Designated as safety issue: No ]
  • Duration of surgery [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • Occurrence of post-operative complications [ Time Frame: After 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Conventional laparotomy closure
Procedure: Conventional laparotomy closure
Recommended technique: The laparotomy is closed with a slowly resorbable running suture (f.e. PDS) in a single layer. The length of the suture should approximately be four (4) times the length of the fascial incision. The skin is closed with the usual technique of the department
Active Comparator: 2
Laparotomy closure with mesh augmentation
Procedure: Laparotomy closure with mesh augmentation
Recommended technique: Mesh augmentation can be done in a retromuscular or a prefascial position. By consensus of the initial primary investigators a retromuscular (sublay) position of the mesh was chosen and as a mesh a light weight polypropylene mesh will be used. Retromuscular (sublay): (see reference no. 11: Rogers et al.) At the end of the vascular procedure the plane behind the rectus muscles (retromuscular-preperitoneal) is dissected as in a "Stoppa repair for incisional hernias"

  Eligibility

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

Inclusion Criteria:

  • All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial.
  • All patients should sign the informed consent.

Exclusion Criteria:

  • Patients below 18 years.
  • Pregnancy.
  • Emergency surgery for aortic aneurysm.
  • Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757133

Locations
Belgium
Stedelijk Ziekenhuis Aalst
Aalst, Belgium, 9300
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium, 2650
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
University Hospital Ghent
Ghent, Belgium, 9000
AZ Maria Middelares Ghent
Ghent, Belgium, 9000
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
CHU Sart Tilman
Liège, Belgium, 4000
Sint Augustinus (GZA ziekenhuizen)
Wilrijk, Belgium, 2610
Sponsors and Collaborators
University Hospital, Ghent
Johnson & Johnson
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
Principal Investigator: Filip Muysoms, MD AZ Maria Middelares Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00757133     History of Changes
Other Study ID Numbers: 2008/379
Study First Received: September 18, 2008
Last Updated: February 5, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014