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Trial record 3 of 5 for:    C-QUR
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Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias (SITUP)

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ClinicalTrials.gov Identifier: NCT01639118
Recruitment Status : Terminated (Perception of an increased incidence of C-Qur V-patch mesh infection, with need for removal, compared to other meshes used for umbilical hernia repair.)
First Posted : July 12, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares

Study Description
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Brief Summary:

Primary ventral hernias, such as umbilical and epigastric 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.

With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.


Condition or disease
Ventral Hernia Umbilical Hernia Epigastric Hernia

Study Design
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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Cohort Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias
Study Start Date : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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 primary umbilical or epigastric 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
  • recurrent umbilical or epigastric hernia
  • incisional or trocar site hernias
  • emergency operations
  • liver cirrhosis or ascites
  • cancer patients
  • concomitant surgery
Contacts and Locations
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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): NCT01639118


Locations
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Belgium
AZ Maria Middelares
Ghent, Oost Vlaanderen, Belgium, 9000
Sponsors and Collaborators
Algemeen Ziekenhuis Maria Middelares
Investigators
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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
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Responsible Party: Stijn De Sutter, Dr. Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT01639118    
Other Study ID Numbers: SITUP-2012
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: November 2012
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
Additional relevant MeSH terms:
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Hernia, Umbilical
Hernia
Hernia, Ventral
 Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases