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Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch (Re-SITUP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761708
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
  Purpose
Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.

Condition Intervention
Ventral Hernia Umbilical Hernia Epigastric Hernia Trocar-site Hernia Procedure: primary ventral hernia repair with mesh

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch

Resource links provided by NLM:


Further study details as provided by Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares:

Primary Outcome Measures:
  • mesh infection [ Time Frame: incidence over 12 months ]

Secondary Outcome Measures:
  • hernia recurrence rate [ Time Frame: incidence over 12 months ]

Enrollment: 57
Study Start Date: March 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
umbilical, epigastric and trocar-site hernia Procedure: primary ventral hernia repair with mesh

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

all adult patients that are planned for surgical repair of a umbilical, epigastric or trocar-site hernia will be considered to enter the study.

Exclusion Criteria:

patients refusing to participate at the follow up visits pregnancy age < 18 years life expectancy less than 12 months emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair

  Contacts and Locations
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): NCT01761708


Locations
Belgium
AZ Maria Middelares
Gent, Belgium, 9000
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
Principal Investigator: Stijn De Sutter, MD Algemeen Ziekenhuis Maria Middelares
Study Director: Filip Muysoms, MD Algemeen Ziekenhuis Maria Middelares
Study Chair: Iris Kyle-Leinhase, PhD Algemeen Ziekenhuis Maria Middelares
  More Information

Responsible Party: Stijn De Sutter, Dr. Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT01761708     History of Changes
Other Study ID Numbers: Re-situp
First Submitted: January 3, 2013
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares:
primary ventral hernia repair with mesh
umbilical hernia repair
epigastric hernia repair
C-Qur V-patch
Size tailored repair
preperitoneal repair
abdominal hernia
dual sided mesh
trocar-site hernia

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