NCT02263599

Brief Summary

The aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,089

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 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

September 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

September 20, 2014

Last Update Submit

July 12, 2023

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • Percentage of conservatively treated ventral hernias that undergo surgery

    Percentage of conservatively treated ventral hernias at the primary surgical consultation, that undergoes surgery (acute or elective) later on

    5 years

Secondary Outcomes (1)

  • Percentage of patient with ventral hernia that are treated conservatively

    5 years

Study Arms (2)

Conservatively treated ventral hernias

Surgically treated ventral hernias

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred to the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014 with the diagnosis ventral hernia

You may qualify if:

  • All patients (older than 18 years) referred to the Surgical Department of Køge University Hospital from 2009 - 2014 with the diagnosis ventral hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Køge University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dunja Kokotovic, MS

    Dept. of Surgery, Køge Hospital

    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

September 20, 2014

First Posted

October 13, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

DK(1)