Ventral HerniaNCT02263625
Regional Differences In Indication for 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 is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of Denmark. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Aug 2015
- 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: Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014
Who may be able to join
- Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of Denmark.
Read the detailed description
30 outpatient consultation will be taped and distributed among hernia surgeons in different regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the treatment and surgical technique.
- Conditions
- Ventral Hernia
- Keywords
- Indication, Differences
- Medical subject headings
- Hernia, Ventral
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in indication for ventral hernia repair
Number of patients offered a ventral hernia repair after primary consultation by different hernia specialists.
Measured: 6 months
Secondary outcomes (1)
Differences in choice of surgical technique between surgeons
Which surgical approach does different surgeons offer patients with a ventral hernia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral 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
- Prospective
- Enrolment
- 30 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
- Dunja Kokotovic, MS, Principal investigator, dept. of surgery, Køge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263625
- Sponsor's protocol ID
- DK_03
- Status last verified
- Jun 2018
- First submitted
- 20 Sep 2014
- 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
- Regional Differences In Indication for Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02263625
- Acronym / sponsor ID
- DK_03
- Conditions
- Ventral Hernia
- Keywords
- Indication, Differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Oct 2014 (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 is to investigate whether there are differences in indication for ventral hernia repair and surgical approach among hernia surgeons from different geographical regions of Denmark.
Detailed description
30 outpatient consultation will be taped and distributed among hernia surgeons in different regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the treatment and surgical technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014
Key inclusion criteria (1 listed)
- Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014
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.
Primary outcome
Differences in indication for ventral hernia repair
Time frame: 6 months
Number of patients offered a ventral hernia repair after primary consultation by different hernia specialists.
1 secondary outcome
Differences in choice of surgical technique between surgeons
Time frame: 6 months
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.
Related trials for Ventral Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
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.
Dunja Kokotovic, MS principal investigator
dept. of surgery, Køge University 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 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?
Differences in indication for ventral hernia repair (time frame: 6 months). 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.