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

September 18, 2008
February 5, 2013
November 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00757133 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment
Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm
  • 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
  • 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"
  • Experimental: 1
    Conventional laparotomy closure
    Intervention: Procedure: Conventional laparotomy closure
  • Active Comparator: 2
    Laparotomy closure with mesh augmentation
    Intervention: Procedure: Laparotomy closure with mesh augmentation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00757133
2008/379
No
University Hospital, Ghent
University Hospital, Ghent
Johnson & Johnson
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
Principal Investigator: Filip Muysoms, MD AZ Maria Middelares Ghent
University Hospital, Ghent
February 2013

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