RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
Primary Purpose
Incisional Hernia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ultrapro® mesh
Premilene® mesh
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia
Eligibility Criteria
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
Sites / Locations
- Department of Surgery, University Hospital Aachen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ultrapro®
Premilene®
Arm Description
Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.
Participants received incisional hernia repair with a Premilene mesh in a sublay technique.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
postoperative seroma
Fluid collection in the wound area
wound infection
Clinical identification of superficial and deep wound infections.
haematoma
hematoma in the wound area
hematoma requiring surgery
hematoma in the wound area requiring surgery
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.
hernia recurrence
hernia recurrence is defined as a new abdominal wall defect in the area of surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961346
Brief Title
RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
Official Title
Sublay Technique With Retromuscular Mesh Augmentation for Incisional Hernia Repair - A Prospective Randomized Multicentre Trial Comparing "Lightweight" Versus "Heavyweight" Meshes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2004 (Actual)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University
4. Oversight
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
5. Study Description
Brief 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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrapro®
Arm Type
Experimental
Arm Description
Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.
Arm Title
Premilene®
Arm Type
Experimental
Arm Description
Participants received incisional hernia repair with a Premilene mesh in a sublay technique.
Intervention Type
Device
Intervention Name(s)
Ultrapro® mesh
Intervention Description
large-pore, lightweight polypropylene mesh
Intervention Type
Device
Intervention Name(s)
Premilene® mesh
Intervention Description
small-pore, heavyweight polypropylene mesh
Primary Outcome Measure Information:
Title
foreign body sensation
Description
Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery.
Time Frame
12 month after surgery
Secondary Outcome Measure Information:
Title
postoperative seroma
Description
Fluid collection in the wound area
Time Frame
24 month
Title
wound infection
Description
Clinical identification of superficial and deep wound infections.
Time Frame
24 month
Title
haematoma
Description
hematoma in the wound area
Time Frame
5 days
Title
hematoma requiring surgery
Description
hematoma in the wound area requiring surgery
Time Frame
5 days
Title
chronic pain
Description
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.
Time Frame
24 month
Title
hernia recurrence
Description
hernia recurrence is defined as a new abdominal wall defect in the area of surgery
Time Frame
24 month
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf D Hilgers, Professor
Organizational Affiliation
Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, University Hospital Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
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