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Self-Expanding Multi-Layered Partially Resorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment of Small and Medium Umbilical Ventral Hernias

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ClinicalTrials.gov Identifier: NCT01307696
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
Jan Bontinck, Algemeen Ziekenhuis Maria Middelares

Brief Summary:
Meshes-devices using dual-sided mesh technology have been developed for the specific indication of small ventral hernias. The design of these meshes allows introduction of a mesh of appropriate size to cover the hernia defect, through a small incision. This technique is very attractive for the surgeon and the patients because the mesh usually can be introduced through a nearly invisible scar in the umbilicus. The avoidance of fixation sutures omits the pain related to these sutures. Short-term results and patient satisfaction are very favorable, encouraging the surgeons to continue with the technique, although long-term results of these meshes in good quality studies are lacking.

Condition or disease
Umbilical Hernia

Detailed Description:
The aim of this study is to evaluate the safety and efficacy at 12 months after repair of small and medium ventral hernias using PVP™. All patients operated between March 2009 and February 2011 at the participating centers, will be evaluated and described. Patients will be evaluated by clinical investigation, questioning and ultrasound. The investigators' main focus will be the incidence of complications related to the use of the device, during the first year. Also the investigators look at recurrence rate at 12 months, occurrence of pain at 12 months and foreign body feeling. The trial can be seen as a quality control of a cohort of patients treated with an innovative mesh device. No sponsoring from the company J&J will be asked or accepted.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Prospective Clinical Registry To Evaluate The Safety And Efficacy Of A Self-Expanding Multi-Layered Partially Resorbable Absorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment Of Small And Medium Umbilical Ventral Hernias
Study Start Date : August 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources




Primary Outcome Measures :
  1. Hernia recurrence [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011, are eligible for the trial.
Criteria

Inclusion Criteria:

  • All patients that were treated at the participating centres with a PVP™ for the repair of an umbilical hernia or another abdominal wall hernia before February 2011.

Exclusion Criteria:

  • no informed consent from the patient.
  • patients lost to follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307696


Locations
Belgium
AZ Maria Middelares
Ghent, Oost Vlaanderen, Belgium, 9000
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
Principal Investigator: Jan Bontinck Algemeen Ziekenhuis Maria Middelares

Publications of Results:
Responsible Party: Jan Bontinck, Doctor, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT01307696     History of Changes
Other Study ID Numbers: MM
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by Jan Bontinck, Algemeen Ziekenhuis Maria Middelares:
Umbilical Hernia Repair
PVP Mesh

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Umbilical
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases