CompletedNCT00323141Updated Dec 7, 2022

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

An interventional study of Ventralex versus Leight Weight Vypro II prothesis in Hernia, Umbilical, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Hernia, Umbilical

Browse trials for

Hernia, Umbilical 67

Keywords

Hernia umbilicalis

In context

Hernia, Umbilical

67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.

Browse Hernia, Umbilical studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Browse University Hospital, Ghent studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Symptomatic hernia umbilicalis
> 18 years old

Exclusion criteria

Exclusion Criteria:

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (estimated)

Study arms

Active comparator
Ventralex
Device: Ventralex versus Leight Weight Vypro II prothesis
Active comparator
Leight Weight Vypro II prothesis
Device: Ventralex versus Leight Weight Vypro II prothesis

Interventions

DeviceVentralex versus Leight Weight Vypro II prothesis
Ventralex and Leight Weight Vypro II prothesis are compared.

What researchers measure

Primary outcomes

Number of relapses after 1 and 3 years
Time frame: after 1 and 3 years

Secondary outcomes

Duration of surgery
Time frame: Depends from type of surgery.
Duration of hospitalisation
Time frame: Depends from type of surgery.
Frequency of complications
Time frame: After 1 and 3 years.
Pain assessment
Time frame: After 1 and 3 years.

Study locations

1 site

University Hospital Ghent
Ghent, 9000, Belgium

References and documents

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2016 to primary completion in Aug 2017, 17 months.

Of 19 interventional studies with no phase under Hernia, Umbilical, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: May 7, 2006
First posted: May 9, 2006
StartActual: Mar 11, 2016
Primary completionActual: Aug 31, 2017
CompletionActual: Aug 31, 2017
Last update: Dec 7, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00323141
Lead sponsor: University Hospital, Ghent
Responsible party: Sponsor
First posted: May 9, 2006
Start date: Mar 11, 2016
Primary completion: Aug 31, 2017
Completion: Aug 31, 2017
Last update: Dec 7, 2022

Study contacts

Frederik Berrevoet, MD, PhD

principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hernia, Umbilical →

Other studies from this sponsor

University Hospital, Ghent →

Start the discussion