Intraperitoneal Mesh With 3cm Overlap Versus a Rives-Stoppa NCT00323141

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

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

Recruitment information / eligibility
Status	Completed
Enrollment	50
Est. completion date	August 31, 2017
Est. primary completion date	August 31, 2017
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Symptomatic hernia umbilicalis - > 18 years old Exclusion Criteria: -

Device:
• Ventralex versus Leight Weight Vypro II prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.

Locations
Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors *(1)*
Lead Sponsor	Collaborator
University Hospital, Ghent

Belgium,

Outcome
Type	Measure	Time frame
Primary	Number of relapses after 1 and 3 years	after 1 and 3 years
Secondary	Duration of surgery	Depends from type of surgery.
Secondary	Duration of hospitalisation	Depends from type of surgery.
Secondary	Frequency of complications	After 1 and 3 years.
Secondary	Pain assessment	After 1 and 3 years.

See also
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Completed	`NCT04941170` - U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia	Phase 4
Completed	`NCT02813382` - Spinal Anesthesia for Outpatient Abdominal Wall Surgery: Comparison of Bupivacaine, 2-chloroprocaine and Prilocaine	N/A