Complication of Surgical ProcedureNCT04849702
Comparison of the Clavien-Dindo and Comprehensive Complication Index
An observational study of Complication of Surgical Procedure and Colorectal Disorders, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication of Surgical Procedure, Colorectal Disorders, Clavien Dindo
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2012to 1 Dec 2020
- How long will I take part?
- 1 Year
- 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: Data of patients in which complications occurring after surgical procedures, performed between October 2012 and September 2013, were recorded.
Who may be able to join
- Only patients that underwent a colorectal resection were included
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.
Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.
Read the detailed description
Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.
- Conditions
- Complication of Surgical Procedure, Colorectal Disorders, Clavien Dindo, Comprehensive Complication Index
- Being tested
- No intervention was compared
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was comparedProcedure or surgery
No intervention was compared
| Study group | Role | What they receive |
|---|---|---|
| Postoperative complication after colorectal resection | Documentation of all postoperative complications after colorectal resections Receives: Procedure: No intervention was compared |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: 1 year
Total in-hospital costs
Measured: 1 year
Secondary outcomes (1)
Length of ICU stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start20 Oct 2012
- Primary completion20 Sep 2013
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel MC Smeyers, MD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849702
- Sponsor's protocol ID
- 2020007
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 19 Apr 2021
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.
- ClinicalTrials.gov ID
- NCT04849702
- Acronym / sponsor ID
- 2020007
- Conditions
- Complication of Surgical Procedure, Colorectal Disorders, Clavien Dindo, Comprehensive Complication Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 20 Oct 2012 (actual)
- Primary completion
- 20 Sep 2013 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 19 Apr 2021 (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.
Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.
Detailed description
Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative complication after colorectal resection | – | Procedure: No intervention was comparedDocumentation of all postoperative complications after colorectal resections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data of patients in which complications occurring after surgical procedures, performed between October 2012 and September 2013, were recorded.
Key inclusion criteria (1 listed)
- Only patients that underwent a colorectal resection were included
Key exclusion criteria (1 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 |
|---|---|---|
| No intervention was comparedNo intervention was compared | Procedure or surgery | Postoperative complication after colorectal resection |
Primary outcome
Length of hospital stay
Time frame: 1 year
Total in-hospital costs
Time frame: 1 year
1 secondary outcome
Length of ICU stay
Time frame: 1 year
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 19 Apr 2021.
- 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.
Karel MC Smeyers, MD principal investigator
Jessa 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 Complication of Surgical Procedure and Colorectal Disorders, run by Jessa Hospital at 1 site in Belgium.
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 19 Apr 2021. 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 Belgium. 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: 1 year). The study lists 2 primary outcomes in all. 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 19 Apr 2021.