RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961346
• Other study ID #: Ultrapo-Studie
• Status: Completed
• Phase: N/A
• Start date: September 2004
• Est. completion date: June 2009

Study information

• Verified date: July 2021
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: June 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Device:
• Ultrapro® mesh
large-pore, lightweight polypropylene mesh
• Premilene® mesh
small-pore, heavyweight polypropylene mesh

Locations

Country	Name	City	State
Germany	Department of Surgery, University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative seroma	Fluid collection in the wound area	24 month
Secondary	wound infection	Clinical identification of superficial and deep wound infections.	24 month
Secondary	haematoma	hematoma in the wound area	5 days
Secondary	hematoma requiring surgery	hematoma in the wound area requiring surgery	5 days
Secondary	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
Secondary	hernia recurrence	hernia recurrence is defined as a new abdominal wall defect in the area of surgery	24 month