Skip to main content
OpenTrials
Completed

NCT Number: NCT04961346

RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

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®.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrapro® mesh

Device

large-pore, lightweight polypropylene mesh

Premilene® mesh

Device

small-pore, heavyweight polypropylene mesh

Primary outcomes

  1. foreign body sensation

    Time frame: 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 outcomes

  1. postoperative seroma

    Time frame: 24 month

    Fluid collection in the wound area

  2. wound infection

    Time frame: 24 month

    Clinical identification of superficial and deep wound infections.

  3. haematoma

    Time frame: 5 days

    hematoma in the wound area

  4. hematoma requiring surgery

    Time frame: 5 days

    hematoma in the wound area requiring surgery

  5. chronic pain

    Time frame: 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.

  6. hernia recurrence

    Time frame: 24 month

    hernia recurrence is defined as a new abdominal wall defect in the area of surgery

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Sublay Technique With Retromuscular Mesh Augmentation for Incisional Hernia Repair - A Prospective Randomized Multicentre Trial Comparing "Lightweight" Versus "Heavyweight" Meshes

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Jul 14, 2021
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.