Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

Completed

• Conditions: Ventral Hernia
• Interventions: Device: Intramesh T1 implantation

• Registration Number: NCT01816867
• Lead Sponsor: be Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a ventral hernia	Intramesh T1 implantation	-

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 12 months determined by clinical examination	12 months

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium