Ventral Hernia
Conditions
Keywords
hernia, Treatment, laparoscopic, open technique
Brief summary
The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.
Interventions
DEVICEIntramesh T1 implantation
Sponsors
be Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is older than 18 years * Written informed consent is obtained from patient * Patient with a primary or incisional ventral hernia
Exclusion criteria
* Patient with a recurrent ventral hernia * Patient with ASA class 5 and 6 * Patient underwent emergency surgery * Patient is pregnant * Patient with a known allergy to components of the ePTFE prosthesis * Patient has a life expectancy less than 1 year * Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate at 12 months determined by clinical examination | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative complications | peri-procedural | Defined as complications occurring during index-procedure from skin-into-skin. The following events must be reported in the case report form: * enterotomy (bowel injury) * major bleeding requiring blood transfusion or reintervention * complications due to anesthesia * minor bleeding at a trocar insertion site |
| Post-operative complications | up to 30 days | Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form: * local numbness * hematoma * seroma * superficial trocar site infection * mesh infection * hernia recurrence * death |
| Seroma | 1 month | The rate of seroma at 1 month after index-procedure. |
| Freedom from hernia-related reinterventions | 12 months | Reinterventions at 12 months after index-procedure |
| Late complications | 12 months | Late complications at 12 months after index-procedure: * prolonged pain more than 8 weeks * local numbness * hernia recurrence |
Countries
Belgium
Outcome results
None listed