Parastomal HerniaNCT03792243
Outcomes After Parastomal Hernia Repair
An observational study of Parastomal Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish Patients Registry. Specifically, the readmission and reoperation rates will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Complication
- Type of treatment
- Surgery or procedure
- How many people
- 1,062 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 1 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing parastomal hernia repair in Denmark from 2007-2017
Who may be able to join
- All patients undergoing parastomal hernia repair in Denmark from 2007-2017
Who cannot join
- If data is not fully registered in the Danish Hernia Database
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.
Read the detailed description
The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is available from the Danish Hernia Database. All healthcare services in Denmark are registered in the Danish National Patients Registry and data on 30-day readmission rate, readmission diagnosis and reoperation is found here. Each Danish citizen has a unique personal identification number and by merging data from the Danish Hernia Database and National Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 focusing on readmission and reoperation rates.
- Conditions
- Parastomal Hernia
- Being tested
- Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComplicationProcedure or surgery
Readmission, reoperation
| Study group | Role | What they receive |
|---|---|---|
| Parastomal hernia | Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017 Receives: Procedure: Complication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Number of patients re-operated for a complication after a parastomal hernia repair
Measured: 30 days
Secondary outcomes (2)
Readmission
Number of patients readmitted after parastomal hernia repair
Measured: 90 days
Recurrence
Number of patients operated for recurrence after a parastomal hernia repair
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 May 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- 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
- 1,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Hernia Database
- Responsible party
- Principal investigator, Frederik Helgstrand, Zealand University Hospital
- Investigators
- Nadia Henriksen, Principal investigator, Zealand University Hospital, Koege, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792243
- Sponsor's protocol ID
- Parastomalhernia 2019
- Status last verified
- Jul 2023
- First submitted
- 2 Jan 2019
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Parastomal Hernia Repair
- ClinicalTrials.gov ID
- NCT03792243
- Acronym / sponsor ID
- Parastomalhernia 2019
- Conditions
- Parastomal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,062 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Danish Hernia Database
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 3 Jan 2019 (actual)
- 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 current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.
Detailed description
The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is available from the Danish Hernia Database. All healthcare services in Denmark are registered in the Danish National Patients Registry and data on 30-day readmission rate, readmission diagnosis and reoperation is found here. Each Danish citizen has a unique personal identification number and by merging data from the Danish Hernia Database and National Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 focusing on readmission and reoperation rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parastomal hernia | – | Procedure: ComplicationPatients undergoing parastomal hernia repair in Denmark between 2007 and 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing parastomal hernia repair in Denmark from 2007-2017
Key inclusion criteria (1 listed)
- All patients undergoing parastomal hernia repair in Denmark from 2007-2017
Key exclusion criteria (1 listed)
- If data is not fully registered in the Danish Hernia Database
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComplicationReadmission, reoperation | Procedure or surgery | Parastomal hernia |
Primary outcome
Reoperation
Time frame: 30 days
Number of patients re-operated for a complication after a parastomal hernia repair
2 secondary outcomes
Readmission
Time frame: 90 days
Recurrence
Time frame: 10 years
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 14 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Nadia Henriksen principal investigator
Zealand University Hospital, Koege, Dept. of Surgery
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 Parastomal 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 14 Jul 2023. 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?
Reoperation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2023.