Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment (PRIMAAT)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Ghent
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
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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 May 23, 2013