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

A

Algemeen Ziekenhuis Maria Middelares

Status

Terminated

Conditions

Umbilical Hernia
Epigastric Hernia
Ventral Hernia

Study type

Observational

Funder types

Other

Identifiers

NCT01639118
SITUP-2012

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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