Clinical trial NCT01761708: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventral Hernia
Umbilical Hernia
Epigastric Hernia
Trocar-site Hernia
Keywords: 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
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

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.


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

Primary outcomes:
measure: mesh infection
timeFrame: incidence over 12 months
Secondary outcomes:
measure: hernia recurrence rate
timeFrame: incidence over 12 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Stijn De Sutter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Filip Muysoms, MD
role: STUDY_DIRECTOR
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Iris Kyle-Leinhase, PhD
role: STUDY_CHAIR
References: