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Visible vs. Non-Visible Mesh in Underlay Positon After Repair of Umbilical Hernias (NANEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200405
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dr. Ulrich Dietz, Wuerzburg University Hospital

Brief 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. Furthermore they hope to get some information about the tissue incorporation.

Condition or disease Intervention/treatment Phase
Umbilical Hernia Device: DynaMeshVisible Device: DynaMeshCICAT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Morphological Imaging of Meshes in Underlay Position After Treatment of Primary Umbilical Hernias: a Randomised Controlled Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: DynaMeshVisible
the umbilical hernia will be fixed with a mesh, which is incorporated with Fe3O4 particles to become visible in MRI
Device: DynaMeshVisible
The umbilical hernias will be fixed with a mesh. In this group a MRI-visible mesh will be used.

Active Comparator: DynaMeshCICAT
the umbilical hernia will be fixed with a Non-MRI-visible PVDF Mesh
Device: DynaMeshCICAT
The umbilical hernias will be fixed with a mesh. In this group a non-visible mesh will be used.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. MRI visibility and visible size of the mesh 12 months after operation [ Time Frame: 12 months ]
    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

  2. intraoperative and postoperative complications (30-day morbidity) [ Time Frame: 4 weeks ]
    There will be registered if there are any intraoperative or postoperative complications

  3. relapse 12 months after operation [ Time Frame: 12 months ]
    There will be registered if there is an relapse 12 months after operation.

  4. life quality 4 weeks and 12 months after operation [ Time Frame: 12 months ]
    There will be done a questionnaire 4 weeks and 12 months after operation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • umbilical hernia > 0,4 cm; <= 3 cm
  • BMI > 20; < 51

Exclusion Criteria:

  • emergency operation
  • previous abdominal operation
  • epigastric hernia in more than 3 cm distance of the umbilical hernia
  • ascites
  • hepatic insufficiency
  • periumbilical skin disease
  • incisional umbilical hernia
  • claustrophobia
  • contraindications concerning the MRI examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200405


Locations
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Germany
Universitätsklinikum Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Ulrich Dietz, Prof Dr Dr Wuerzburg UH
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Responsible Party: Prof. Dr. Dr. Ulrich Dietz, Prof., Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03200405    
Other Study ID Numbers: Dietz_87/16-sc
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Prof. Dr. Dr. Ulrich Dietz, Wuerzburg University Hospital:
umbilical hernia
mesh repair
MRI-visibility
underlay
NANEP
DynaMeshCICAT
DynaMeshVisible
preperitoneal
Additional relevant MeSH terms:
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Hernia, Umbilical
Hernia
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal