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OpenTrials
Completed

NCT Number: NCT01183325

Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation

For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.

About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).

With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.

The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.

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Key information

Conditions

Umbilical Hernias Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventral Hernias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imelda Hospital, Bonheiden, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient
  • Written informed consent
  • Umbilical, primary ventral hernias smaller than 3cm diameter

Exclusion criteria

  • Hernias larger than 3cm
  • Recurrence
  • Children
  • Emergency cases
  • Incisional hernias

Treatment and study plan

Proceed Ventral Patch placement

Device

Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control

Primary outcomes

  1. Percentage of adequately placed patches

    Time frame: At T 0 days

Secondary outcomes

  1. Perioperative morbidity rate

    Time frame: Within 30 days

  2. Pre- and postoperative pain

    Time frame: At T 0 day, T 30 days and T 1 year

  3. Number of patients needed a repositioning of the patch

    Time frame: At T 0 days

  4. Reasons for inadequate positioning

    Time frame: At T 0 days

  5. Number of repositioning necessary

    Time frame: At T 0 days

  6. Complication ratio

    Time frame: At 1 year

  7. Recurrence rate at 1 year

    Time frame: At 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Aug 17, 2010
Registry last updated
Dec 5, 2014

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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