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

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 - Pro-DMH-Register

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031191

Enrollment

600

Registered

2023-02-07

Start date

2023-01-23

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epigastric Hernias, Hiatus Hernias, Prevention and Treatment of Incisional Hernias, Inguinal Hernias, Umbilical Hernias, Treatment and Prevention of Parastomal Hernias

Interventions

Group 1: The present study is a non-interventional (observational study/registry study) as part of regular surgical practice for the treatment/prevention of hernias using polyvinylidene fluoride (PVDF

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: As this is an observation of routine clinical practice, only patients who do not meet the inclusion criteria are excluded.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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

Measure	Time frame
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	—

Countries

Germany, Monaco

Contacts

Public ContactUwe Klinge

Uniklinik RWTH Aachen

uklinge@ukaachen.de+49 241 80 89501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026