Umbilical Hernia Clinical Trial
— NANEPOfficial title:
Morphological Imaging of Meshes in Underlay Position After Treatment of Primary Umbilical Hernias: a Randomised Controlled Trial
NCT number | NCT03200405 |
Other study ID # | Dietz_87/16-sc |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | July 2018 |
Verified date | January 2019 |
Source | Wuerzburg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 76 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Wuerzburg | Wuerzburg |
Lead Sponsor | Collaborator |
---|---|
Wuerzburg University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 4 weeks | |
Secondary | 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 | 12 months | |
Secondary | intraoperative and postoperative complications (30-day morbidity) | There will be registered if there are any intraoperative or postoperative complications | 4 weeks | |
Secondary | relapse 12 months after operation | There will be registered if there is an relapse 12 months after operation. | 12 months | |
Secondary | life quality 4 weeks and 12 months after operation | There will be done a questionnaire 4 weeks and 12 months after operation. | 12 months |
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