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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Conventional laparotomy closure |
|
| 2 | Active Comparator | Laparotomy closure with mesh augmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional laparotomy closure | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of incisonal hernia | 1 year and 5 years after surgery | |
| VAS scores of pain at rest | 12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Berrevoet, MD | University Hospital, Ghent | Principal Investigator |
| Filip Muysoms, MD | AZ Maria Middelares Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stedelijk Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| Universitair Ziekenhuis Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26943336 | Derived | Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr;263(4):638-45. doi: 10.1097/SLA.0000000000001369. |
| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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|
| Laparotomy closure with mesh augmentation | Procedure | 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" |
|
| Duration of surgery |
| After surgery |
| Occurrence of post-operative complications | After 1 month |
| Antwerp |
| 2650 |
| Belgium |
| Imelda Ziekenhuis | Bonheiden | 2820 | Belgium |
| AZ Maria Middelares Ghent | Ghent | 9000 | Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| CHU Sart Tilman | Liège | 4000 | Belgium |
| Sint Augustinus (GZA ziekenhuizen) | Wilrijk | 2610 | Belgium |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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