Chirurgische aandoening: Littekenbreuken, preventief Incisional hernia
Conditions
Interventions
An elective laparotomy through a midline incision will be performed. The
operating vascular surgeon will close the abdomen wall as described below:
First, the midline fascia will be closed with a ru
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Elective midline laparotomy for patients with Abdominal Aortic Aneurysm. - Age >= 18 years. - Signed informed consent by patient.
Exclusion criteria
Exclusion criteria: - Pregnancy. - Emergency procedures. - Inclusion in other trials with interference of the primary endpoint. - Life expectancy less than 24 months (as estimated by the attending physician). - Immune suppression therapy within 2 weeks before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is safety in terms of intra-operative and postoperative complications. Intra-operatively the feasibility of the product in this setting will be assessed, the time of implantation of the mesh will be recorded, any problems encountered by the researcher after each procedure will be asked. Post-operative complications including surgical site occurrence (SSO) according to the Ventral Hernia Working Group (surgical site infection (SSI), seroma, wound dehiscence, enterocutaneous fistula, wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch absess, seroma, hematoma and infected or exposed mesh), SSOs requiring a procedural intervention (SSOPI) defined as wound opening or debridement, suture excision, percutaneous drainage, or mesh removal. Other post-operative complications compromise pulmonary infections and ventilation problems. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints compromise the presence of incisional hernia as determined by physical examination or ultrasonography. Size (length, width, diameter in cm) and location of the incisional hernia will be recorded. Location will be recorded relative to the abdomen (peri-umbilical, infra-umbilical, supra-umbilical, or lateral), and relative to the mesh (edge of the mesh, outside of the mesh covered area, or within the mesh covered area). Incisional hernia is defined as any abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging, as determined by Korenkov et al. and accepted by the European Hernia Society. An incisional hernia is defined as *symptomatic* if the hernia causes pain, discomfort, incarceration, or cosmetic complaints. Post-operative pain (VAS score) and quality of life (MOS SF-36, EQ-5D questionnaires and Carolinas Comfort Scale) will be obtained. During follow-up visits sensitivity of the skin in the area of the mesh placement will be assessed. | — |
Countries
Netherlands
Outcome results
None listed