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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Bontinck, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier:
NCT01307696
First received: March 2, 2011
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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
Umbilical Hernia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Algemeen Ziekenhuis Maria Middelares:

Primary Outcome Measures:
  • Hernia recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Jan Bontinck, Doctor, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT01307696     History of Changes
Other Study ID Numbers: MM
Study First Received: March 2, 2011
Last Updated: April 25, 2014
Health Authority: Belgium: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014