Outcome AssessmentNCT05675904
Textbook Outcome in Colon Carcinoma
An observational study of Outcome Assessment and Cancer of Colon, run by Hospital General Universitario de Alicante at 1 site in Spain.
Trial summary
BACKGROUND: Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome Assessment, Cancer of Colon
- What is being tested?
- Colon oncological resection
- Type of treatment
- Surgery or procedure
- How many people
- 564 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective colon cancer resection with confirmed histological diagnosis
Who may be able to join
- Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study
Who cannot join
- Age under 18 years
- Emergency surgery
- Resections of the rectum or resections for pathologies other than cancer
- Follow-up of less than two years (with the exception of patients who died)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.
BACKGROUND:
Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer.
Read more
MATERIAL AND METHODS:
Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.
The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.
- Conditions
- Outcome Assessment, Cancer of Colon
- Being tested
- Colon oncological resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon oncological resectionProcedure or surgery
Scheduled colon cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Yes Textbook Outcome | Patients undergoing scheduled colon cancer surgery with a R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days Receives: Procedure: Colon oncological resection | |
| No Textbook outcome | Patients undergoing scheduled colon cancer surgery without any of the following items: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days Receives: Procedure: Colon oncological resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook Outcome
analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled colon cancer resection
Measured: September 2012- August 2016
Overall survival
relationship between Textbook Outcome and overall survival
Measured: From surgery to 160 months
disease-free survival
relationship between Textbook Outcome and disease-free survival
Measured: From surgery to 160 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jan 2022
- Primary completion28 Jun 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 Outcome AssessmentStudies 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
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candido Fernando Alcazar-Lopez, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675904
- Sponsor's protocol ID
- 12/2022
- Status last verified
- Jan 2023
- First submitted
- 17 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.
- ClinicalTrials.gov ID
- NCT05675904
- Acronym / sponsor ID
- 12/2022
- Conditions
- Outcome Assessment, Cancer of Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 9 Jan 2023 (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.
BACKGROUND:
Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer.
MATERIAL AND METHODS:
Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.
The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yes Textbook Outcome | – | Procedure: Colon oncological resectionPatients undergoing scheduled colon cancer surgery with a R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days |
| No Textbook outcome | – | Procedure: Colon oncological resectionPatients undergoing scheduled colon cancer surgery without any of the following items: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective colon cancer resection with confirmed histological diagnosis
Key inclusion criteria (1 listed)
- Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study
Key exclusion criteria (4 listed)
- Age under 18 years
- Emergency surgery
- Resections of the rectum or resections for pathologies other than cancer
- Follow-up of less than two years (with the exception of patients who died)
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 |
|---|---|---|
| Colon oncological resectionScheduled colon cancer surgery | Procedure or surgery | No Textbook outcome, Yes Textbook Outcome |
Primary outcome
Textbook Outcome
Time frame: September 2012- August 2016
analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled colon cancer resection
Overall survival
Time frame: From surgery to 160 months
relationship between Textbook Outcome and overall survival
disease-free survival
Time frame: From surgery to 160 months
relationship between Textbook Outcome and disease-free survival
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 9 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Outcome Assessment and Cancer of Colon, run by Hospital General Universitario de Alicante at 1 site in Spain.
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 4 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 9 Jan 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 Spain. 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?
Textbook Outcome (time frame: September 2012- August 2016). The study lists 3 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 9 Jan 2023.