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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
ClinicalTrials.gov Identifier:
NCT01761708
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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 Algemeen Ziekenhuis Maria Middelares:

Primary Outcome Measures:
  • mesh infection [ Time Frame: incidence over 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hernia recurrence rate [ Time Frame: incidence over 12 months ] [ Designated as safety issue: No ]

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

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 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
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: 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

No publications provided

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
Study First Received: January 3, 2013
Last Updated: January 3, 2013
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
trocar-site hernia

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

ClinicalTrials.gov processed this record on July 28, 2014