Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

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Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ventral Hernia

Interventions

Intramesh T1 implantationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Outcomes

Primary Outcomes

Recurrence rate at 12 months determined by clinical examination

Time frame: 12 months

Secondary Outcomes

Intraoperative complications

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

Time frame: peri-procedural

Post-operative complications

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

Time frame: up to 30 days

Seroma

The rate of seroma at 1 month after index-procedure.

Time frame: 1 month

Freedom from hernia-related reinterventions

Reinterventions at 12 months after index-procedure

Time frame: 12 months

Late complications

Late complications at 12 months after index-procedure: * prolonged pain more than 8 weeks * local numbness * hernia recurrence

Time frame: 12 months

Data from ClinicalTrials.gov

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