Incisional Hernia
Conditions
Brief summary
In this randomized, controlled, prospective multicentre clinical trial with a parallel group design a large-pore, lightweight polypropylene mesh (Ultrapro®) is compared to a small-pore, heavyweight polypropylene mesh (Premilene®), within a standardized, retromuscular mesh augmentation to identify the superiority of the lightweight mesh. Included patients are examined at five scheduled follow-up visits (5 and 21 days, 4, 12 and 24 months after surgery). The primary outcome criterion is foreign body sensation 12 month after surgery. Further secondary endpoint criteria are the occurrence of haematoma or haematoma requiring surgery at the 5-day visit, seroma, wound infection, and chronic pain within 24 months postoperatively. Quality of life was investigated by the SF-36®.
Interventions
DEVICEUltrapro® mesh
large-pore, lightweight polypropylene mesh
DEVICEPremilene® mesh
small-pore, heavyweight polypropylene mesh
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter
Exclusion criteria
* hernia of other location * recurrent hernia * incarcerated hernia * emergency surgery * patients with a malignancy or chemotherapy within the last 3 months * pregnancy * participation in other studies * patients with a wound infection * missing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| foreign body sensation | 12 month after surgery | Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative seroma | 24 month | Fluid collection in the wound area |
| wound infection | 24 month | Clinical identification of superficial and deep wound infections. |
| hernia recurrence | 24 month | hernia recurrence is defined as a new abdominal wall defect in the area of surgery |
| hematoma requiring surgery | 5 days | hematoma in the wound area requiring surgery |
| chronic pain | 24 month | Chronic pain is defined as pain sensations that persist for more than 3 months after surgery. A Visual Analog Scale (VAS) with a range of 0-10 is used as a tool to measure pain. |
| haematoma | 5 days | hematoma in the wound area |
Countries
Germany
Outcome results
None listed