Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment
NCT ID: NCT00757133
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2008-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Conventional laparotomy closure
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
2
Laparotomy closure with mesh augmentation
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"
Interventions
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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
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 Criteria
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Inclusion Criteria
* All patients should sign the informed consent.
Exclusion Criteria
* Pregnancy.
* Emergency surgery for aortic aneurysm.
* Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.
18 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Frederik Berrevoet, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Filip Muysoms, MD
Role: PRINCIPAL_INVESTIGATOR
AZ Maria Middelares Ghent
Locations
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Stedelijk Ziekenhuis Aalst
Aalst, , Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
AZ Maria Middelares Ghent
Ghent, , Belgium
University Hospital Ghent
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
CHU Sart Tilman
Liège, , Belgium
Sint Augustinus (GZA ziekenhuizen)
Wilrijk, , Belgium
Countries
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References
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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.
Related Links
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Website of the University Hospital Ghent
Other Identifiers
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2008/379
Identifier Type: -
Identifier Source: org_study_id