Prospective observational study for the evaluation of recurrences/primary hernias and technical or postoperative complications in the context of surgical practice for the treatment/prevention of abdominal wall, inguinal, diaphragm and parastomal hernias with DynaMesh® mesh implants
Recruiting
- Conditions
- Epigastric Hernias, Hiatus Hernias, Prevention and Treatment of Incisional Hernias, Inguinal Hernias, Umbilical Hernias, Treatment and Prevention of Parastomal Hernias
- Registration Number
- DRKS00031191
- Lead Sponsor
- FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Indication for the treatment/prevention of an abdominal wall, inguinal, diaphragmatic and/or parastomal hernia with a corresponding DynaMesh® mesh implant
Exclusion Criteria
As this is an observation of routine clinical practice, only patients who do not meet the inclusion criteria are excluded.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The MDR (EU 2017/745) calls on manufacturers to establish proactive and systematic processes that make it possible to collect information about the safety and performance in routine use of medical devices already on the market in order to derive potentially necessary preventive and corrective measures.<br>The establishment of a hernia register, which will serve the systematic documentation of data on safety and performance, is the structural goal required by the MDR in the sense of a systematic PMCF.
- Secondary Outcome Measures
Name Time Method The secondary objectives are associated with clinical data that is recorded in the register in order to be able to evaluate the clinical and technical safety and performance of the relevant products after reclassification by the MDR and to be able to systematically monitor them in the further course