Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias (SITUP)

This study has been 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.)
Sponsor:
Information provided by (Responsible Party):
Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier:
NCT01639118
First received: July 10, 2012
Last updated: November 18, 2012
Last verified: November 2012

July 10, 2012
November 18, 2012
March 2012
August 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01639118 on ClinicalTrials.gov Archive Site
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Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias
Prospective Observational Cohort Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

community sample

  • Ventral Hernia
  • Umbilical Hernia
  • Epigastric Hernia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01639118
SITUP-2012
No
Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
Algemeen Ziekenhuis Maria Middelares
Not Provided
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
Algemeen Ziekenhuis Maria Middelares
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP