An interventional study of Ultrapro® mesh and Premilene® mesh in Incisional Hernia, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Treatment
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®.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 188 is above the median of 80 across 739 interventional studies indexed under Hernia.
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Exclusion Criteria:
Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.
Device: Ultrapro® mesh
Participants received incisional hernia repair with a Premilene mesh in a sublay technique.
Device: Premilene® mesh
large-pore, lightweight polypropylene mesh
small-pore, heavyweight polypropylene mesh
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University