N/A
N=126
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01848184 ↗Enrolled (actual)
126
Serious AEs
16.7%
Results posted
Jul 2018
Primary outcome: Primary: Primary Hernia Recurrence Rate at 24 Month Follow-up. — 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PARIETEX™ Composite Ventral Patch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Hernia Recurrence Rate at 24 Month Follow-up. |
3 | — |
| SECONDARY Recurrence Rate at 1, 6 and 12 Month Follow-up |
0; 2; 3 | — |
Summary
The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.
Eligibility Criteria
Inclusion Criteria
- All patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach
- Signed informed consent form by the patient or the legally authorized representative
- Intraoperative inclusion criteria : Size of the defect: ≤ 4 cm
Exclusion Criteria
- Emergency procedure
- Current participation in other trials
- History of previous hernia at the same location.
- Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
- Patient 35
- ASA score ≥ 4
- The investigator determined that the patient will not be able to comply with the required follow-up visits
Data sourced from ClinicalTrials.gov (NCT01848184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.