RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

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

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 Overview

• Status: Completed
• Conditions: Incisional Hernia
• Intervention / Treatment: Device: Ultrapro® mesh; Device: Premilene® mesh

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Department of Surgery, University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrapro®; Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.	Device: Ultrapro® mesh; large-pore, lightweight polypropylene mesh
Experimental: Premilene®; Participants received incisional hernia repair with a Premilene mesh in a sublay technique.	Device: Premilene® mesh; small-pore, heavyweight polypropylene mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative seroma	Fluid collection in the wound area	24 month
wound infection	Clinical identification of superficial and deep wound infections.	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

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Ralf D Hilgers, Professor, Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2004
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: Ultrapo-Studie

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No