NCT01665859

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,783

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

4 years

First QC Date

August 13, 2012

Last Update Submit

July 12, 2023

Conditions

Umbilical HerniaEpigastric Hernia

Keywords

readmissionrecurrenceumbilicalepigastricherniaoutcomemorbidity

Outcome Measures

Primary Outcomes (1)

  • readmission

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

    30 days

Secondary Outcomes (1)

  • reoperation for recurrence

    up to 4 years

Study Arms (1)

Danish Ventral Hernia Database

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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Umbilical or epigastric hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Hernia, UmbilicalRecurrenceHernia

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Frederik Helgstrand, MD

    dept. surgery, Køge sygehus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 15, 2012

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

July 1, 2012

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

DK(1)