ClinicalTrials.gg
CompletedNCT01665859Updated Jul 13, 2023

Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair

An observational study in Umbilical Hernia and Epigastric Hernia, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-13.

Sponsored by Zealand University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,783
Ages
18 Years to 120 Years
Sex
All
01

Study summary

Umbilical and epigastric hernia repairs are common and performed by numerous surgical techniques. Considering that the hernia repairs in general are relatively small and simple procedures there are disproportionate poor results.

The aim of present study is to determine surgical risk factors for readmission after umbilical and epigastric hernia repair and to report risk factors for later reoperation for recurrence.

Read the detailed description

All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

02

Conditions studied

  • Umbilical Hernia
  • Epigastric Hernia

Keywords

  • readmission
  • recurrence
  • umbilical
  • epigastric
  • hernia
  • outcome
  • morbidity
03

In context

Hernia, Umbilical

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

This study's enrollment of 6,783 is above the median of 118 across 25 observational studies indexed under Hernia, Umbilical.

Browse Hernia, Umbilical studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All elective umbilical or epigastric hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Inclusion criteria

  • Umbilical or epigastric hernia repair

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,783 participants (actual)

Groups and cohorts

  • Danish Ventral Hernia Database

    Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010

06

What researchers measure

Primary outcomes

  1. readmission

    Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair

    Time frame: 30 days

Secondary outcomes

  1. reoperation for recurrence

    Risk factors for recurrence repair after umbilical or epigastric hernia repair

    Time frame: up to 4 years

07

Study locations

1 site
  • Køge Hospital
    Køge, 4600, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of Jan 2011 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.

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

Registered
Aug 13, 2012
First posted
Aug 15, 2012
Start
Jan 2007
Primary completionActual
Jan 2011
CompletionActual
Jul 2012
Last update
Jul 13, 2023
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 Jul 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01665859
Responsible party
Frederik Helgstrand (MD, Zealand University Hospital) — Principal investigator
First posted
Aug 15, 2012
Start date
Jan 2007
Primary completion
Jan 2011
Completion
Jul 2012
Last update
Jul 13, 2023

Study contacts

Frederik Helgstrand, MD
principal investigator · dept. surgery, Køge sygehus, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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