An observational study in Umbilical Hernia, sponsored by Algemeen Ziekenhuis Maria Middelares. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-28.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Observational
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.
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 100 is below the median of 115 across 26 observational studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Hernia recurrence
Time frame: 1 year
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Algemeen Ziekenhuis Maria Middelares