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

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ClinicalTrials.gov Identifier: NCT01761708
Recruitment Status : Unknown
Verified January 2013 by Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares.
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares

Tracking Information
First Submitted Date January 3, 2013
First Posted Date January 7, 2013
Last Update Posted Date January 7, 2013
Study Start Date March 2012
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2013)
mesh infection [ Time Frame: incidence over 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 3, 2013)
hernia recurrence rate [ Time Frame: incidence over 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch
Official Title Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population community sample
Condition
  • Ventral Hernia
  • Umbilical Hernia
  • Epigastric Hernia
  • Trocar-site Hernia
Intervention Procedure: primary ventral hernia repair with mesh
Study Groups/Cohorts umbilical, epigastric and trocar-site hernia
Intervention: Procedure: primary ventral hernia repair with mesh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: January 3, 2013)
57
Original Actual Enrollment Same as current
Estimated Study Completion Date August 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761708
Other Study ID Numbers Re-situp
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
Study Sponsor Algemeen Ziekenhuis Maria Middelares
Collaborators Not Provided
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
PRS Account Algemeen Ziekenhuis Maria Middelares
Verification Date January 2013