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®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
188
large-pore, lightweight polypropylene mesh
small-pore, heavyweight polypropylene mesh
Department of Surgery, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
foreign body sensation
Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery.
Time frame: 12 month after surgery
postoperative seroma
Fluid collection in the wound area
Time frame: 24 month
wound infection
Clinical identification of superficial and deep wound infections.
Time frame: 24 month
haematoma
hematoma in the wound area
Time frame: 5 days
hematoma requiring surgery
hematoma in the wound area requiring surgery
Time frame: 5 days
chronic pain
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.
Time frame: 24 month
hernia recurrence
hernia recurrence is defined as a new abdominal wall defect in the area of surgery
Time frame: 24 month
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