RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

RWTH Aachen University

Status: Completed

Conditions: Incisional Hernia

Treatments: Device: Premilene® mesh; Device: Ultrapro® mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT04961346

Ultrapo-Studie

Details and patient eligibility

About

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®.

Enrollment: 188 patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

188 participants in 2 patient groups

Ultrapro®

Experimental group

Description:

Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.

Treatment:

Device: Ultrapro® mesh

Premilene®

Experimental group

Description:

Participants received incisional hernia repair with a Premilene mesh in a sublay technique.

Treatment:

Device: Premilene® mesh