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OpenTrials
Completed

NCT Number: NCT01816867

Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intramesh T1 implantation

Device

Other names: Intramesh T1 Cousin Biotech

Primary outcomes

  1. Recurrence rate at 12 months determined by clinical examination

    Time frame: 12 months

Secondary outcomes

  1. Intraoperative complications

    Time frame: 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

  2. Post-operative complications

    Time frame: 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

  3. Seroma

    Time frame: 1 month

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

  4. Freedom from hernia-related reinterventions

    Time frame: 12 months

    Reinterventions at 12 months after index-procedure

  5. Late complications

    Time frame: 12 months

    Late complications at 12 months after index-procedure:

    • prolonged pain more than 8 weeks
    • local numbness
    • hernia recurrence

Sponsors and collaborators

Lead sponsor

be Medical

Industry

Registry information

Official study title

Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2013
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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