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
  Purpose

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
Ventral Hernia
Umbilical Hernia
Epigastric Hernia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Algemeen Ziekenhuis Maria Middelares:

Enrollment: 11
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639118

Locations
Belgium
AZ Maria Middelares
Ghent, Oost Vlaanderen, 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

No publications provided

Responsible Party: Stijn De Sutter, Dr. Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier: NCT01639118     History of Changes
Other Study ID Numbers: SITUP-2012
Study First Received: July 10, 2012
Last Updated: November 18, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by 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:
Hernia
Hernia, Abdominal
Hernia, Umbilical
Hernia, Ventral
Pathological Conditions, Anatomical
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 29, 2014