Ventral HerniaLOSHERNIANCT01388634
Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair
An observational study of Ventral Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- How many people
- 2,258 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients registered in The Danish Ventral Hernia Database in 2008
Who may be able to join
- patients with elective ventral hernia repair in Denmark 2008
Who cannot join
- emergency repairs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nationwide Analysis of Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair
The aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery
Read the detailed description
Detailed analysis of reasons for prolonged hospital stay and readmission in patients undergoing a ventral hernia repair
- Conditions
- Ventral Hernia
- Keywords
- Length of hospital stay, readmission, ventral hernia
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients with prolonged length of hospital stay (>5 days) or readmission after ventral hernia repair | |
| control group | Patients without prolonged length of hospital stay (>5 days) or readmission after ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
analyse factors associated with prolonged length of hospital stay (minimum 5 days).
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (1)
Readmission
reasons for readmission after a ventral hernia repair
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Helgstrand, Zealand University Hospital
- Investigators
- Frederik Helgstrand, MD, Principal investigator, Dept. surgery Køge hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388634
- Sponsor's protocol ID
- Køge hospital
- Acronym
- LOSHERNIA
- Status last verified
- Jun 2018
- First submitted
- 27 Jun 2011
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Nationwide analysis of prolonged hospital stay and readmission after elective ventral hernia repair. Dan Med Bull. 2011 Oct;58(10):A4322.
PubMed 21975153
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Analysis of Prolonged Hospital Stay and Readmission After Elective Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01388634
- Acronym / sponsor ID
- LOSHERNIA / Køge hospital
- Conditions
- Ventral Hernia
- Keywords
- Length of hospital stay, readmission, ventral hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,258 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to analyse factors associated with prolonged length of hospital stay, readmission and death in a nationwide group of patients undergoing elective ventral hernia repair in search for areas of interest to improve outcome after ventral hernia surgery
Detailed description
Detailed analysis of reasons for prolonged hospital stay and readmission in patients undergoing a ventral hernia repair
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | –Patients with prolonged length of hospital stay (>5 days) or readmission after ventral hernia repair |
| control group | – | –Patients without prolonged length of hospital stay (>5 days) or readmission after ventral hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients registered in The Danish Ventral Hernia Database in 2008
Key inclusion criteria (1 listed)
- patients with elective ventral hernia repair in Denmark 2008
Key exclusion criteria (1 listed)
- emergency repairs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
analyse factors associated with prolonged length of hospital stay (minimum 5 days).
1 secondary outcome
Readmission
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Derived from this study: PubMed 21975153Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Nationwide analysis of prolonged hospital stay and readmission after elective ventral hernia repair. Dan Med Bull. 2011 Oct;58(10):A4322.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Helgstrand, MD principal investigator
Dept. surgery Køge hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.