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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrapro® | Experimental | Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique. |
|
| Premilene® | Experimental | Participants received incisional hernia repair with a Premilene mesh in a sublay technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrapro® mesh | Device | large-pore, lightweight polypropylene mesh |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative seroma | Fluid collection in the wound area | 24 month |
| wound infection | Clinical identification of superficial and deep wound infections. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf D Hilgers, Professor | Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, University Hospital Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36635466 | Derived | Kroh A, Zufacher M, Eickhoff R, Heise D, Helmedag M, Ulmer F, Neumann UP, Conze J, Hilgers RD, Binnebosel M. No difference in outcomes between large- and small-pore meshes in a prospective, randomized, multicenter trial investigating open retromuscular meshplasty for incisional hernia repair. Langenbecks Arch Surg. 2023 Jan 13;408(1):22. doi: 10.1007/s00423-022-02751-x. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| Premilene® mesh |
| Device |
small-pore, heavyweight polypropylene mesh |
|
| 24 month |
| haematoma | hematoma in the wound area | 5 days |
| hematoma requiring surgery | hematoma in the wound area requiring surgery | 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. | 24 month |
| hernia recurrence | hernia recurrence is defined as a new abdominal wall defect in the area of surgery | 24 month |
| D010335 | Pathologic Processes |