Parastomal HerniaPAHEREPNCT01484743
Risk Factors for Morbidity After Parastomal Hernia Repair
An observational study of Parastomal Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair. 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?
- differences in surgical techniques
- Type of treatment
- Surgery or procedure
- How many people
- 199 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All incisional hernia repairs registered in the Danish National Hernia Database from January 1st 2007 to December 31st 2010
Who may be able to join
- All parastomal hernia repairs registered in the Danish National Ventral Hernia Database
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair
The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.
Read the detailed description
All principal parastomal 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.
- Conditions
- Parastomal Hernia
- Being tested
- differences in surgical techniques
- Keywords
- recurrence, readmission, reoperation, mortality, morbidity
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
differences in surgical techniquesProcedure or surgery
follow the risk for morbidity after incisional hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Patients with parastomal hernia repair | Patients registered in the Danish Ventral Hernia database Receives: Procedure: differences in surgical techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence repair
Surgical risk factors for recurrence repair after parastomal hernia repair.
Measured: up to 4 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionOct 2011
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.
- 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
- Prospective
- Enrolment
- 199 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 Koege hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484743
- Sponsor's protocol ID
- Parastoma
- Acronym
- PAHEREP
- Status last verified
- Jun 2018
- First submitted
- 30 Nov 2011
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
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 Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair
- ClinicalTrials.gov ID
- NCT01484743
- Acronym / sponsor ID
- PAHEREP / Parastoma
- Conditions
- Parastomal Hernia
- Keywords
- recurrence, readmission, reoperation, mortality, morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Dec 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 Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.
Detailed description
All principal parastomal 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with parastomal hernia repair | – | Procedure: differences in surgical techniquesPatients registered in the Danish Ventral Hernia database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All incisional hernia repairs registered in the Danish National Hernia Database from January 1st 2007 to December 31st 2010
Key inclusion criteria (1 listed)
- All parastomal hernia repairs registered in the Danish National Ventral Hernia Database
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| differences in surgical techniquesfollow the risk for morbidity after incisional hernia repair | Procedure or surgery | Patients with parastomal hernia repair |
Primary outcome
Recurrence repair
Time frame: up to 4 years after operation
Surgical risk factors for recurrence repair after parastomal hernia repair.
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.
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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 Koege 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 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 0 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?
Recurrence repair (time frame: up to 4 years after operation). 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 27 Jun 2018.