Umbilical HerniaNANEPNCT03200405
Visible vs. Non-Visible Mesh in Underlay Positon After Repair of Umbilical Hernias
A study testing DynaMeshVisible and DynaMeshCICAT in people with Umbilical Hernia, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to determine the exact position of a mesh which is placed in underlay position in umbilical hernia in vitro. The investigators want to gain information if the mesh lays directly next to the abdominal wall fascia or if there´s fat tissue between mesh and fascia. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- DynaMeshVisible and DynaMeshCICAT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to Jul 2018
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- umbilical hernia > 0,4 cm; <= 3 cm
- BMI > 20; < 51
Who cannot join
- emergency operation
- previous abdominal operation
- epigastric hernia in more than 3 cm distance of the umbilical hernia
- ascites
- hepatic insufficiency
- periumbilical skin disease
Show all 9Show fewer
- incisional umbilical hernia
- claustrophobia
- contraindications concerning the MRI examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphological Imaging of Meshes in Underlay Position After Treatment of Primary Umbilical Hernias: a Randomised Controlled Trial
The purpose of this study is to determine the exact position of a mesh which is placed in underlay position in umbilical hernia in vitro. The investigators want to gain information if the mesh lays directly next to the abdominal wall fascia or if there´s fat tissue between mesh and fascia. Furthermore they hope to get some information about the tissue incorporation.
Read the detailed description
The literature tells to supply umbilical hernia with a mesh, that overlaps 5-6 cm in each direction. To achieve this overlap an extensive taxidermy is necessary, which causes a big operation trauma. An umbilical hernia is an extended physiological stoma and compared to an incisional hernia has no risk to rip further. Therefore the researchers act on the assumption that this generous overlap is not necessary. For a short time there is a new mesh available, which combines all the necessary requirements as elasticity, effective porousness and a structure of monofilaments with MRI visibility. In a randomised clinical trial two sorts of meshes, a conventional PVDF(polyvinylidene fluoride) mesh (DynaMesh-CICAT) and a MRI visible PVDF(polyvinylidene fluoride) mesh (DynaMeshVisible) shall be compared.The investigators postulate that there is no difference between the two groups concerning complications, relapse and life quality after 4 weeks and 12 months. Altogether the goal of the study is to determine the exact position of the mesh in vitro.
The study design is a double-blinded, multicentric randomised controlled study. The radiologist and the examiner are blinded. It will be reported according to the CONSORT Statements.
The eligibility criteria is written anywhere else. The operation results after an single shot antibiotics in open method. The access happens via a semicircular infraumbilical cut. There will be prepared until the linea alba and the umbilical hernia orifice to display the hernia gap and the hernia sac. If there´s only a fat prolapse, it will be removed by ligation. If there´s an peritoneal hernia sac, the content will be repositioned and the hernia sac will be removed. The preperitoneal space will be prepared bluntly and the peritoneum will be released from the rectus sheath. A 4-6 cm trimmed mesh with a central thread will be inserted in underlay position. The central thread is used for orientation. The hernial gap will be closed in transversal direction with absorbable threads. After the reinsertion of the navel the region of the operation will be closed with subcutaneous und intracutaneous seams.
The randomisation succeeded via block randomisation at a ratio of 1 to 1. A randomisation list with SAS®-Makros "Randomisation Tables" by M. Stout is already created. There is one list for Wuerzburg and one for Kitzingen. In total there are 72 assignments created, instead of 50. But upon consultation the recruitment will be stopped after the 50th patient. According to the calculations of the epidemiological departement of the University of Wuerzburg there are 22 patients needed in each arm, that means 44 patients in total to reach the confidence interval. The patient data will be imported to EuraHS. This data entry is based on the ethics committee vote of the medical departement of Wuerzburg dated the 31th of july 2012 (application number 256/11) and the renewal of the 21st of july 2015.
If there´s an increased complication rate in one of the groups or the morphology of the MRI-visible meshes is found unsatisfactory the study will be cancelled.
The patient data will be recorded via pseudonyms.
- Conditions
- Umbilical Hernia
- Being tested
- DynaMeshVisible, DynaMeshCICAT
- Keywords
- umbilical hernia, mesh repair, MRI-visibility, underlay, NANEP, DynaMeshCICAT, DynaMeshVisible, preperitoneal
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaMeshVisibleDevice
The umbilical hernias will be fixed with a mesh. In this group a MRI-visible mesh will be used.
DynaMeshCICATDevice
The umbilical hernias will be fixed with a mesh. In this group a non-visible mesh will be used.
| Study group | Role | What they receive |
|---|---|---|
| DynaMeshVisible | Experimental | the umbilical hernia will be fixed with a mesh, which is incorporated with Fe3O4 particles to become visible in MRI Receives: Device: DynaMeshVisible |
| DynaMeshCICAT | Active comparator | the umbilical hernia will be fixed with a Non-MRI-visible PVDF Mesh Receives: Device: DynaMeshCICAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI visibility and visible size of the mesh 4 weeks after operation
A MRI will be done 4 weeks after the operation and it will be registered if the mesh is visible; furthermore there will be done some measurements to specify the exact position and the visible size of the mesh
Measured: 4 weeks
Secondary outcomes (4)
MRI visibility and visible size of the mesh 12 months after operation
A MRI will be done 12 months after the operation and it will be registered if the mesh is visible; furthermore there will be done some measurements to specify the exact position and the visible size of the mesh
Measured: 12 months
intraoperative and postoperative complications (30-day morbidity)
There will be registered if there are any intraoperative or postoperative complications
Measured: 4 weeks
relapse 12 months after operation
There will be registered if there is an relapse 12 months after operation.
Measured: 12 months
life quality 4 weeks and 12 months after operation
There will be done a questionnaire 4 weeks and 12 months after operation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study startOct 2016
- Primary completionJul 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Ulrich Dietz, Wuerzburg University Hospital
- Investigators
- Ulrich Dietz, Prof Dr Dr, Principal investigator, Wuerzburg UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200405
- Sponsor's protocol ID
- Dietz_87/16-sc
- Acronym
- NANEP
- Status last verified
- Jan 2019
- First submitted
- 23 May 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Imaging of Meshes in Underlay Position After Treatment of Primary Umbilical Hernias: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03200405
- Acronym / sponsor ID
- NANEP / Dietz_87/16-sc
- Conditions
- Umbilical Hernia
- Keywords
- umbilical hernia, mesh repair, MRI-visibility, underlay, NANEP, DynaMeshCICAT, DynaMeshVisible, preperitoneal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 Jun 2017 (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.
The purpose of this study is to determine the exact position of a mesh which is placed in underlay position in umbilical hernia in vitro. The investigators want to gain information if the mesh lays directly next to the abdominal wall fascia or if there´s fat tissue between mesh and fascia. Furthermore they hope to get some information about the tissue incorporation.
Detailed description
The literature tells to supply umbilical hernia with a mesh, that overlaps 5-6 cm in each direction. To achieve this overlap an extensive taxidermy is necessary, which causes a big operation trauma. An umbilical hernia is an extended physiological stoma and compared to an incisional hernia has no risk to rip further. Therefore the researchers act on the assumption that this generous overlap is not necessary. For a short time there is a new mesh available, which combines all the necessary requirements as elasticity, effective porousness and a structure of monofilaments with MRI visibility. In a randomised clinical trial two sorts of meshes, a conventional PVDF(polyvinylidene fluoride) mesh (DynaMesh-CICAT) and a MRI visible PVDF(polyvinylidene fluoride) mesh (DynaMeshVisible) shall be compared.The investigators postulate that there is no difference between the two groups concerning complications, relapse and life quality after 4 weeks and 12 months. Altogether the goal of the study is to determine the exact position of the mesh in vitro.
The study design is a double-blinded, multicentric randomised controlled study. The radiologist and the examiner are blinded. It will be reported according to the CONSORT Statements.
The eligibility criteria is written anywhere else. The operation results after an single shot antibiotics in open method. The access happens via a semicircular infraumbilical cut. There will be prepared until the linea alba and the umbilical hernia orifice to display the hernia gap and the hernia sac. If there´s only a fat prolapse, it will be removed by ligation. If there´s an peritoneal hernia sac, the content will be repositioned and the hernia sac will be removed. The preperitoneal space will be prepared bluntly and the peritoneum will be released from the rectus sheath. A 4-6 cm trimmed mesh with a central thread will be inserted in underlay position. The central thread is used for orientation. The hernial gap will be closed in transversal direction with absorbable threads. After the reinsertion of the navel the region of the operation will be closed with subcutaneous und intracutaneous seams.
The randomisation succeeded via block randomisation at a ratio of 1 to 1. A randomisation list with SAS®-Makros "Randomisation Tables" by M. Stout is already created. There is one list for Wuerzburg and one for Kitzingen. In total there are 72 assignments created, instead of 50. But upon consultation the recruitment will be stopped after the 50th patient. According to the calculations of the epidemiological departement of the University of Wuerzburg there are 22 patients needed in each arm, that means 44 patients in total to reach the confidence interval. The patient data will be imported to EuraHS. This data entry is based on the ethics committee vote of the medical departement of Wuerzburg dated the 31th of july 2012 (application number 256/11) and the renewal of the 21st of july 2015.
If there´s an increased complication rate in one of the groups or the morphology of the MRI-visible meshes is found unsatisfactory the study will be cancelled.
The patient data will be recorded via pseudonyms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DynaMeshVisible | Experimental | Device: DynaMeshVisiblethe umbilical hernia will be fixed with a mesh, which is incorporated with Fe3O4 particles to become visible in MRI |
| DynaMeshCICAT | Active comparator | Device: DynaMeshCICATthe umbilical hernia will be fixed with a Non-MRI-visible PVDF Mesh |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- umbilical hernia > 0,4 cm; <= 3 cm
- BMI > 20; < 51
Key exclusion criteria (9 listed)
- emergency operation
- previous abdominal operation
- epigastric hernia in more than 3 cm distance of the umbilical hernia
- ascites
- hepatic insufficiency
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 |
|---|---|---|
| DynaMeshVisibleThe umbilical hernias will be fixed with a mesh. In this group a MRI-visible mesh will be used. | Device | DynaMeshVisible |
| DynaMeshCICATThe umbilical hernias will be fixed with a mesh. In this group a non-visible mesh will be used. | Device | DynaMeshCICAT |
Primary outcome
MRI visibility and visible size of the mesh 4 weeks after operation
Time frame: 4 weeks
A MRI will be done 4 weeks after the operation and it will be registered if the mesh is visible; furthermore there will be done some measurements to specify the exact position and the visible size of the mesh
4 secondary outcomes
MRI visibility and visible size of the mesh 12 months after operation
Time frame: 12 months
intraoperative and postoperative complications (30-day morbidity)
Time frame: 4 weeks
relapse 12 months after operation
Time frame: 12 months
life quality 4 weeks and 12 months after operation
Time frame: 12 months
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 17 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Ulrich Dietz, Prof Dr Dr principal investigator
Wuerzburg UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynaMeshVisible and DynaMeshCICAT in people with Umbilical Hernia, run by Wuerzburg University Hospital 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 2 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 17 Jan 2019. 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?
MRI visibility and visible size of the mesh 4 weeks after operation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2019; AzTrials last refreshed its copy on 26 Oct 2026.