Prospective observational study to evaluate recurrences and surgical or postoperative complications after surgical treatment of parastomal hernia with DynaMesh®-IPST-R

Prospective observational study to evaluate recurrences and surgical or postoperative complications after surgical treatment of parastomal hernia with DynaMesh®-IPST-R - Pro-IPST-R-Register

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034469

Enrollment

Registered

2024-07-30

Start date

2020-06-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

K43.3

Interventions

Group 1: All adult patients of legal age who are scheduled to receive a DynaMesh® IPST-R (visible) mesh implant for a parastomal hernia requiring treatment. Due to the nature of the study, only data d

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All adult patients with legal capacity who are to have a DynaMesh® IPST-R (visible) mesh implant inserted due to a parastomal hernia requiring treatment. The consent form was signed by the patient after oral and written information about participation in the registry study.

Exclusion criteria

Exclusion criteria: As this is an observation of routine clinical practice, no patients meeting the inclusion criteria will be excluded.

Design outcomes

Primary

Measure	Time frame
The primary study objective arises from the changes to the MDR, which brought with it a tightening of the so-called post-market surveillance in the sense of proactive market monitoring. The MDR requires manufacturers to establish proactive and systematic processes that make it possible to collect information on the safety and performance in the routine use of medical devices already on the market in order to derive potentially necessary preventive and corrective measures.	—

Measure

Time frame

The primary study objective arises from the changes to the MDR, which brought with it a tightening of the so-called post-market surveillance in the sense of proactive market monitoring. The MDR requires manufacturers to establish proactive and systematic processes that make it possible to collect information on the safety and performance in the routine use of medical devices already on the market in order to derive potentially necessary preventive and corrective measures.

—

Secondary

Measure	Time frame
The detection of potential mesh-related complications (seroma, chronic pain, infection, fistula formation, erosion, adhesion, obstruction/ileus)	—

Countries

Germany

Contacts

Public ContactLutz Mirow

Klinikum Chemnitz gGmbH

chirurgie@skc.de+49 371 333-33300

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 19, 2026