Postoperative Wound BreakdownNCT03008265
Fascial Dehiscence and Mortality
An observational study of Postoperative Wound Breakdown, run by Kristian Kiim Jensen at 1 site in Denmark.
Trial summary
Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence. The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Wound Breakdown
- What is being tested?
- Postoperative fascial dehiscence
- How many people
- 9,000 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent open colonic resection for carcinoma in the period 2001-2008 in Denmark.
Who may be able to join
- All patients who underwent open colonic resection identified in the DCCG
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Digestive Disease Center, Bispebjerg Hospital
Copenhagen NV, Copenhagen, DK-2400
About this study
Official title: Just a Fascial Dehiscence? Nationwide Cohort Study on the Mortality Associated With Fascial Dehiscence After Colonic Resection
Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence.
The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.
- Conditions
- Postoperative Wound Breakdown
- Being tested
- Postoperative fascial dehiscence
- Keywords
- Fascial dehiscence, Mortality
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative fascial dehiscenceOther
| Study group | Role | What they receive |
|---|---|---|
| Colonic cancer resection | Not described Receives: Other: Postoperative fascial dehiscence |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year mortality
Measured: Three years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound BreakdownStudies 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
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristian Kiim Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Kiim Jensen, Bispebjerg Hospital
- Investigators
- Kristian K Jensen, MD, Principal investigator, Digestive Disease Center, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008265
- Sponsor's protocol ID
- 2016-Fascial-dehiscence-mort
- Status last verified
- Dec 2016
- First submitted
- 29 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just a Fascial Dehiscence? Nationwide Cohort Study on the Mortality Associated With Fascial Dehiscence After Colonic Resection
- ClinicalTrials.gov ID
- NCT03008265
- Acronym / sponsor ID
- 2016-Fascial-dehiscence-mort
- Conditions
- Postoperative Wound Breakdown
- Keywords
- Fascial dehiscence, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Kristian Kiim JensenUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 2 Jan 2017 (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.
Nationwide cohort study on short- and long-term mortality of patients with and without postoperative fascial dehiscence.
The cohort will be comprised of patient undergoing open colonic resection for colonic cancer registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence and the outcome of interest 30-day, 3- and 5-year mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic cancer resection | – | Other: Postoperative fascial dehiscence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent open colonic resection for carcinoma in the period 2001-2008 in Denmark.
Key inclusion criteria (1 listed)
- All patients who underwent open colonic resection identified in the DCCG
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Postoperative fascial dehiscence | Other | Colonic cancer resection |
Primary outcome
3-year mortality
Time frame: Three years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Kristian K Jensen, MD principal investigator
Digestive Disease Center, Bispebjerg 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 Postoperative Wound Breakdown, run by Kristian Kiim Jensen 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: status not confirmed, as of the sponsor's last update on 2 Jan 2017. 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?
Results are not available in the source record.
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?
3-year mortality (time frame: Three years postoperatively). 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 2 Jan 2017.