Incisional HerniaNCT04961346
RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
A study testing Ultrapro® mesh and Premilene® mesh in people with Incisional Hernia, run by RWTH Aachen University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Ultrapro® mesh and Premilene® mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter
Who cannot join
- hernia of other location
- recurrent hernia
- incarcerated hernia
- emergency surgery
- patients with a malignancy or chemotherapy within the last 3 months
- pregnancy
Show all 9Show fewer
- participation in other studies
- patients with a wound infection
- missing informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Surgery, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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®.
- Conditions
- Incisional Hernia
- Being tested
- Ultrapro® mesh, Premilene® mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrapro® meshDevice
large-pore, lightweight polypropylene mesh
Premilene® meshDevice
small-pore, heavyweight polypropylene mesh
| Study group | Role | What they receive |
|---|---|---|
| Ultrapro® | Experimental | Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique. Receives: Device: Ultrapro® mesh |
| Premilene® | Experimental | Participants received incisional hernia repair with a Premilene mesh in a sublay technique. Receives: Device: Premilene® mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month after surgery
Secondary outcomes (6)
postoperative seroma
Fluid collection in the wound area
Measured: 24 month
wound infection
Clinical identification of superficial and deep wound infections.
Measured: 24 month
haematoma
hematoma in the wound area
Measured: 5 days
hematoma requiring surgery
hematoma in the wound area requiring surgery
Measured: 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.
Measured: 24 month
hernia recurrence
hernia recurrence is defined as a new abdominal wall defect in the area of surgery
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startSep 2004
- Primary completionJun 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Kroh, MD, RWTH Aachen University
- Investigators
- Ralf D Hilgers, Professor, Principal investigator, Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961346
- Sponsor's protocol ID
- Ultrapo-Studie
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kroh A, Zufacher M, Eickhoff R, Heise D, Helmedag M, Ulmer F, Neumann UP, Conze J, Hilgers RD, Binnebosel M. No difference in outcomes between large- and small-pore meshes in a prospective, randomized, multicenter trial investigating open retromuscular meshplasty for incisional hernia repair. Langenbecks Arch Surg. 2023 Jan 13;408(1):22. doi: 10.1007/s00423-022-02751-x.
PubMed 36635466
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublay Technique With Retromuscular Mesh Augmentation for Incisional Hernia Repair - A Prospective Randomized Multicentre Trial Comparing "Lightweight" Versus "Heavyweight" Meshes
- ClinicalTrials.gov ID
- NCT04961346
- Acronym / sponsor ID
- Ultrapo-Studie
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2004 (actual)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrapro® | Experimental | Device: Ultrapro® meshParticipants received incisional hernia repair with an Ultrapro mesh in a sublay technique. |
| Premilene® | Experimental | Device: Premilene® meshParticipants received incisional hernia repair with a Premilene mesh in a sublay technique. |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter
Key exclusion criteria (9 listed)
- hernia of other location
- recurrent hernia
- incarcerated hernia
- emergency surgery
- patients with a malignancy or chemotherapy within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrapro® meshlarge-pore, lightweight polypropylene mesh | Device | Ultrapro® |
| Premilene® meshsmall-pore, heavyweight polypropylene mesh | Device | Premilene® |
Primary outcome
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.
6 secondary outcomes
postoperative seroma
Time frame: 24 month
wound infection
Time frame: 24 month
haematoma
Time frame: 5 days
hematoma requiring surgery
Time frame: 5 days
chronic pain
Time frame: 24 month
hernia recurrence
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Derived from this study: PubMed 36635466Kroh A, Zufacher M, Eickhoff R, Heise D, Helmedag M, Ulmer F, Neumann UP, Conze J, Hilgers RD, Binnebosel M. No difference in outcomes between large- and small-pore meshes in a prospective, randomized, multicenter trial investigating open retromuscular meshplasty for incisional hernia repair. Langenbecks Arch Surg. 2023 Jan 13;408(1):22. doi: 10.1007/s00423-022-02751-x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf D Hilgers, Professor principal investigator
Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrapro® mesh and Premilene® mesh in people with Incisional Hernia, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
foreign body sensation (time frame: 12 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.