Research with human participants

Overview of medical research in the Netherlands

A multicentre Prospective study in pAtients undergoing ventral herNia repair by open approach with intrA-peritoneal positioning using parietex* Composite vEntral pAtch.

Published:
Last updated:

Assessing the safety and efficacy of a new mesh (Parietex Composite Ventral Patch)

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Soft tissue therapeutic procedures
Study type
Interventional

ID

NL-OMON40149

Source

ToetsingOnline

Brief title

PANACEA-trial

Condition

  • Soft tissue therapeutic procedures

Synonym

hernia / abdominal wall defect

Research involving

Human

Sponsors and support

Primary sponsor :
Covidien
Source(s) of monetary or material Support :
Covidien

Intervention

Keyword :
epigastric hernia, hernia repair, mesh, umbilical hernia

Outcome measures

Primary outcome

Recurrene rate at 24 months based on physical and ultrasound examination.

Secondary outcome

Recurrence rate at 1,6 and 12 months / pain with NRS, consumption of analgesics

/ ease of mesh, operative details.

Background summary

Analogue to other hernia repairs, more ventral hernia repairs are mesh-based.
It remains unclear which mesh to prefer.

Study objective

Assessing the safety and efficacy of a new mesh (Parietex Composite Ventral
Patch)

Study design

Multicentre cohort study

Intervention

Open mesh-based ventral hernia repair

Study burden and risks

Burden (3 extra visits, an abdominal wall ultrasound at 2 years and a urinary
test for females before inclusion) could be regarded as limited. Risks is the
same as treatment without this trial.

Public
Covidien

avenue de Formans 116
Trevoux 01600
FR
Scientific
Covidien

avenue de Formans 116
Trevoux 01600
FR

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

primary ventral hernia
maximum hernia size 4 cm
adults

Exclusion criteria

emergency procedure
pregnancy known/suspected/planned during study follow-up period

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
15
Type :
Actual

Medical products/devices used

Generic name :
Mesh / Parietex Composite Ventral Patch
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
Other clinicaltrials.gov
CCMO NL43841.060.13

Date completed :
Actual enrolment :
8

Summary results

Trial is onging in other countries