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OpenTrials
Completed

NCT Number: NCT00323141

Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa Repair With a 6cm Overlap in Hernia Umbilicalis

To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.

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Key information

Conditions

Hernia, Umbilical Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic hernia umbilicalis
  • > 18 years old

Exclusion criteria

-

Treatment and study plan

Ventralex versus Leight Weight Vypro II prothesis

Device

Ventralex and Leight Weight Vypro II prothesis are compared.

Primary outcomes

  1. Number of relapses after 1 and 3 years

    Time frame: after 1 and 3 years

Secondary outcomes

  1. Duration of surgery

    Time frame: Depends from type of surgery.

  2. Duration of hospitalisation

    Time frame: Depends from type of surgery.

  3. Frequency of complications

    Time frame: After 1 and 3 years.

  4. Pain assessment

    Time frame: After 1 and 3 years.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 9, 2006
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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