Colorectal CancerCARESS-CCRNCT02488161
Factors Related to Adverse Events in Colorectal Cancer
An observational study of Colorectal Cancer, run by Hospital Galdakao-Usansolo.
Trial summary
Coordinated multi-center project with several complementary goals in each one of the sub-projects included. Objectives: 1.To determine risk factors of death, or major complications in the short term; 2.To determine risk factors of death, tumor recurrence, major complications, readmission or deterioration of quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 2,600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 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
- No healthy volunteers
- Adult, Older adult
Study population: This prospective cohort study included patients drawn from 22 hospitals belonging to the Spanish National Health Service (SNS), which covers the majority (99.8%) of the population of Spain. All covered residents have free access to their primary care physician and to the ED of the hospitals. All of the hospitals have similar technological and human resources. Patients with a diagnosis of colon or rectum cancer attending the surgical services of any of these hospitals to undergo surgery between June 2010 and December 2012 were informed of the goals of the study and invited to voluntarily participate.
Who may be able to join
- Patients were eligible for the study if they were included in the surgical waiting list of one of the participating hospitals with a diagnosis of surgically resectable colon or rectum cancer. Colon or rectum cancer diagnosis was based on anatomopathological diagnosis after a biopsy by colonoscopy. Inclusion criteria were having diagnosed with colon cancer (up to 15 cm above the anal margin) and rectum (between the anal margin and 15 cm above it), where curative and / or palliative surgery for treatment by first time were applied and who sign the informed consent to participate in the study consent.
Who cannot join
- Exclusion criteria were colon or rectum in situ cancer, unresectable tumor, severe mental or physical conditions which preclude the patient to respond to questionnaires, terminal patients, patients unable to respond to questionnaires from any cause or who do not give their consent to participate in the study.
About this study
Official title: Risk Factors of Adverse Outcomes at Short and Medium Term, and Development of Predictive Models, in Patients With Colorectal Cancer. IRYSS-coordinated Multicenter Study
Coordinated multi-center project with several complementary goals in each one of the sub-projects included. Objectives: 1.To determine risk factors of death, or major complications in the short term; 2.To determine risk factors of death, tumor recurrence, major complications, readmission or deterioration of quality of life in the mid term; 3.Evaluation of patient reported outcomes from before the intervention to the end of the follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar adverse results. This sub-project (coordinator) will approach the determination of risk factors of death, tumor recurrence, major complications, readmission and deterioration of quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2 years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6 Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic, immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to study. Statistic analysis: a derivation sample will be created where the possible predicting parameters will be identified, by cancer of colon or rectum. Predictive models will be created with a good discriminative capacity. A validation of those models will be performed in a validation sub-sample. Logistic and Cox regression models will be used. Simulation models for the prediction of discreet events in the long term will be used.
Read the detailed description
This prospective cohort study included patients drawn from 22 hospitals belonging to the Spanish National Health Service (SNS), which covers the majority (99.8%) of the population of Spain. All covered residents have free access to their primary care physician and to the emergency departments of the hospitals. All of the hospitals have similar technological and human resources.
Patients with a diagnosis of colon cancer attending the surgical services of any of these hospitals to undergo surgery between June 2010 and December 2012 were informed of the goals of the study and invited to voluntarily participate. In order to take part in the study, a patient had to provide informed consent. All information was kept confidential. The Institutional Review Boards of the participating hospitals approved this project.
Data collected Data collected upon hospital admission included information on sociodemographic data, clinical data (including information about onset of symptoms, habits, personal and family background, comorbidities, diagnostic tests, pre-intervention treatments), preoperative data (including analytical, tumor markers and diagnostic tests), data of the outpatient anesthesia data on the surgical intervention, pathology data, and data related to the remaining days of admission (including the presence of complications, need for reintervention or death). Subsequently, data were collected up to 30 days after surgery (analytical, diagnostic tests, presence of complications, readmissions, reintervention or death). Finally, information was collected through the year including need for radiation therapy, chemotherapy (treatment schedule, cycles, complications of treatment, supportive care), laboratory results and diagnostic tests performed, presence of complications, tumor recurrence, readmission or reintervention and death.
Patients completed the following questionnaires before surgery and one year after surgery: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer), and HADS. The EuroQol-5D is a generic HRQoL questionnaire which has demonstrated good psychometric properties and allow for comparison with other populations. It has been translated and validated in Spanish. This instrument consists of two parts: the first is a description of the state of health in five dimensions: mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Each of these dimensions is measured by three answer options that define different levels of severity. The second is a visual analogue scale in which patients rate their health on a scale displayed in the form of a thermometer (20 mm), whose ends are 0 (worst imaginable health state) to 100 (best state imaginable health). The EORTC QLQ-C30 is a questionnaire for evaluating the HRQoL for cancer patients undergoing treatment, which has shown good validity and reliability in its Spanish adaptation (Cronbach's alpha coefficient of 0.7). It is one of the instruments measuring quality of life in cancer patients most commonly used and allow the comparison of the results obtained in patients with colorectal cancer patients with other cancers. It consists of 30 items, 28 of them with four possible answers (in all, a little, a lot, a lot) and two items with seven Alternative (visual analogue scale where one is "very poor" and seven "excellent"). The timeframe should refer to the previous week. The scores on each scale are transformed so that the final values are between 0 and 100. In addition to this overall score, the instrument consists of three scales: Global health status: in which a high score represents a high performance in terms of overall health; Functional -scale: consists of five subscales of operation: physical, role, emotional, cognitive and social; Symptoms scale consisting of a number of symptoms: fatigue, nausea, vomiting, pain, dyspnea, insomnia, decreased appetite, constipation, diarrhea and financial difficulties. A high score on each of these symptoms represents a high level of symptoms or problems in this area. The QLQ-CR29 was then developed after revising the QLQ-CR38, and was demonstrated internationally to have both sufficient validity and reliability to support its use as a supplement to the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings. The QLQ-CR29 contains 29 items, and is described in detail elsewhere. Briefly, there are 18 items addressing gastrointestinal symptoms, pain and problems with micturition, and there are separate scales for the participants with or without a stoma and separate items addressing sexual function for men and women. The response categories for each item are the same as those used in the QLQ-C30.
- Conditions
- Colorectal Cancer
- Being tested
- No intervention
- Keywords
- Colorectal cancer, Risk factors, Adverse events, Predictive models
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer | One cohort of patients with colorectal cancer, studied before the intervention, and one month, one year, two years, three years and five years after. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: up to five years
Secondary outcomes (5)
Number of participants with Readmission
Measured: up to five years
Number of participants with Reintervention
Measured: up to five years
Changes in health-related quality of life (in the questionnaires employed in the study)
Measured: up to five years
Number of participants with Complications
Measured: up to five years
Number of participants with Cancer recurrence
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- 2,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Collaborators
- Fondo de Investigacion Sanitaria, Departamento de Sanidad del Gobierno Vasco (País Vasco, Spain)
- Responsible party
- Principal investigator, JOSE M QUINTANA-LOPEZ, MD PhD, Hospital Galdakao-Usansolo
- Investigators
- Jose M Quintana, PhD, Principal investigator, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488161
- Sponsor's protocol ID
- PS09/00314
- Other IDs
- PS09/00910, PS09/00746, PS09/00805, PI09/90460, PI09/90490, PI09/90453, PI09/90441, PI09/90397
- Acronym
- CARESS-CCR
- Status last verified
- Aug 2016
- First submitted
- 16 Jun 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Orive M, Barrio I, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Cortajarena S, Bilbao A, Aguirre U, Sarasqueta C, Quintana JM; REDISSEC-CARESS/CCR group. Five-year follow-up mortality prognostic index for colorectal patients. Int J Colorectal Dis. 2023 Mar 9;38(1):64. doi: 10.1007/s00384-023-04358-0.
PubMed 36892600Orive M, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, Fernandez de Larrea N, Redondo M, Bilbao A, Sarasqueta C, Aguirre U, Quintana JM; REDISSEC-CARESS/CCR group. Anxiety, depression, health-related quality of life, and mortality among colorectal patients: 5-year follow-up. Support Care Cancer. 2022 Oct;30(10):7943-7954. doi: 10.1007/s00520-022-07177-1. Epub 2022 Jun 23.
PubMed 35737143Quintana JM, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Aguirre U, Briones E, Group FTRCR. Quality Indicators and Outcomes in a Prospective Cohort of Colorectal Cancer Patients. J Gastrointest Cancer. 2023 Mar;54(1):20-26. doi: 10.1007/s12029-021-00779-8. Epub 2021 Dec 10.
PubMed 34893952Gonzalez N, Lorono A, Aguirre U, Lazaro S, Bare M, Redondo M, Briones E, Sarasqueta C, Bilbao A, de Larrea NF, Quintana JM; REDISSEC-CARESS/CCR group. Risk scores to predict mortality 2 and 5 years after surgery for colorectal cancer in elderly patients. World J Surg Oncol. 2021 Aug 26;19(1):252. doi: 10.1186/s12957-021-02356-6.
PubMed 34446044Quintana JM, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S; REDISSEC CARESS-CCR (Results and Health Services Research in Colorectal Cancer)- group. Predictors of readmission and reoperation in patients with colorectal cancer. Support Care Cancer. 2020 May;28(5):2339-2350. doi: 10.1007/s00520-019-05050-2. Epub 2019 Sep 4.
PubMed 31485982Mar J, Anton-Ladislao A, Ibarrondo O, Arrospide A, Lazaro-Aramburu S, Gonzalez N, Bare M, Escobar A, Redondo M, Quintana JM; REDISSEC-CARESS/CCR group. Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer. Surg Endosc. 2020 Mar;34(3):1167-1176. doi: 10.1007/s00464-019-06867-y. Epub 2019 May 28.
PubMed 31140003Orive M, Aguirre U, Gonzalez N, Lazaro S, Redondo M, Bare M, Anula R, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Quintana JM; REDISSEC-CARESS/CCR group. Risk factors affecting hospital stay among patients undergoing colon cancer surgery: a prospective cohort study. Support Care Cancer. 2019 Nov;27(11):4133-4144. doi: 10.1007/s00520-019-04683-7. Epub 2019 Feb 22.
PubMed 30793242Quintana JM, Anton-Ladisla A, Gonzalez N, Lazaro S, Bare M, Fernandez de Larrea N, Redondo M, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S; REDISSEC-CARESS/CCR group. Outcomes of open versus laparoscopic surgery in patients with colon cancer. Eur J Surg Oncol. 2018 Sep;44(9):1344-1353. doi: 10.1016/j.ejso.2018.05.030. Epub 2018 Jun 6.
PubMed 29921557Mar J, Anton-Ladislao A, Ibarrondo O, Arrospide A, Lazaro S, Gonzalez N, Bare M, Callejo D, Redondo M, Quintana JM; REDISSEC-CARESS/CCR group. Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer. Surg Endosc. 2018 Dec;32(12):4912-4922. doi: 10.1007/s00464-018-6250-9. Epub 2018 Jun 4.
PubMed 29869084Arostegui I, Gonzalez N, Fernandez-de-Larrea N, Lazaro-Aramburu S, Bare M, Redondo M, Sarasqueta C, Garcia-Gutierrez S, Quintana JM; REDISSEC CARESS-CCR Group. Combining statistical techniques to predict postsurgical risk of 1-year mortality for patients with colon cancer. Clin Epidemiol. 2018 Mar 6;10:235-251. doi: 10.2147/CLEP.S146729. eCollection 2018.
PubMed 29563837Bare M, Alcantara MJ, Gil MJ, Collera P, Pont M, Escobar A, Sarasqueta C, Redondo M, Briones E, Dujovne P, Quintana JM; CARESS-CCR Study Group. Validity of the CR-POSSUM model in surgery for colorectal cancer in Spain (CCR-CARESS study) and comparison with other models to predict operative mortality. BMC Health Serv Res. 2018 Jan 29;18(1):49. doi: 10.1186/s12913-018-2839-x.
PubMed 29378647Quintana JM, Gonzalez N, Anton-Ladislao A, Redondo M, Bare M, Fernandez de Larrea N, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Aguirre U; REDISSEC-CARESS/CCR group. Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project. BMC Cancer. 2016 Jul 8;16:435. doi: 10.1186/s12885-016-2475-y.
PubMed 27391216
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Adverse Outcomes at Short and Medium Term, and Development of Predictive Models, in Patients With Colorectal Cancer. IRYSS-coordinated Multicenter Study
- ClinicalTrials.gov ID
- NCT02488161
- Acronym / sponsor ID
- CARESS-CCR / PS09/00314
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Risk factors, Adverse events, Predictive models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Collaborators
- Fondo de Investigacion Sanitaria, Departamento de Sanidad del Gobierno Vasco (País Vasco, Spain)
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Jul 2015 (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.
Coordinated multi-center project with several complementary goals in each one of the sub-projects included. Objectives: 1.To determine risk factors of death, or major complications in the short term; 2.To determine risk factors of death, tumor recurrence, major complications, readmission or deterioration of quality of life in the mid term; 3.Evaluation of patient reported outcomes from before the intervention to the end of the follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar adverse results. This sub-project (coordinator) will approach the determination of risk factors of death, tumor recurrence, major complications, readmission and deterioration of quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2 years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6 Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic, immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to study. Statistic analysis: a derivation sample will be created where the possible predicting parameters will be identified, by cancer of colon or rectum. Predictive models will be created with a good discriminative capacity. A validation of those models will be performed in a validation sub-sample. Logistic and Cox regression models will be used. Simulation models for the prediction of discreet events in the long term will be used.
Detailed description
This prospective cohort study included patients drawn from 22 hospitals belonging to the Spanish National Health Service (SNS), which covers the majority (99.8%) of the population of Spain. All covered residents have free access to their primary care physician and to the emergency departments of the hospitals. All of the hospitals have similar technological and human resources.
Patients with a diagnosis of colon cancer attending the surgical services of any of these hospitals to undergo surgery between June 2010 and December 2012 were informed of the goals of the study and invited to voluntarily participate. In order to take part in the study, a patient had to provide informed consent. All information was kept confidential. The Institutional Review Boards of the participating hospitals approved this project.
Data collected Data collected upon hospital admission included information on sociodemographic data, clinical data (including information about onset of symptoms, habits, personal and family background, comorbidities, diagnostic tests, pre-intervention treatments), preoperative data (including analytical, tumor markers and diagnostic tests), data of the outpatient anesthesia data on the surgical intervention, pathology data, and data related to the remaining days of admission (including the presence of complications, need for reintervention or death). Subsequently, data were collected up to 30 days after surgery (analytical, diagnostic tests, presence of complications, readmissions, reintervention or death). Finally, information was collected through the year including need for radiation therapy, chemotherapy (treatment schedule, cycles, complications of treatment, supportive care), laboratory results and diagnostic tests performed, presence of complications, tumor recurrence, readmission or reintervention and death.
Patients completed the following questionnaires before surgery and one year after surgery: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer), and HADS. The EuroQol-5D is a generic HRQoL questionnaire which has demonstrated good psychometric properties and allow for comparison with other populations. It has been translated and validated in Spanish. This instrument consists of two parts: the first is a description of the state of health in five dimensions: mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Each of these dimensions is measured by three answer options that define different levels of severity. The second is a visual analogue scale in which patients rate their health on a scale displayed in the form of a thermometer (20 mm), whose ends are 0 (worst imaginable health state) to 100 (best state imaginable health). The EORTC QLQ-C30 is a questionnaire for evaluating the HRQoL for cancer patients undergoing treatment, which has shown good validity and reliability in its Spanish adaptation (Cronbach's alpha coefficient of 0.7). It is one of the instruments measuring quality of life in cancer patients most commonly used and allow the comparison of the results obtained in patients with colorectal cancer patients with other cancers. It consists of 30 items, 28 of them with four possible answers (in all, a little, a lot, a lot) and two items with seven Alternative (visual analogue scale where one is "very poor" and seven "excellent"). The timeframe should refer to the previous week. The scores on each scale are transformed so that the final values are between 0 and 100. In addition to this overall score, the instrument consists of three scales: Global health status: in which a high score represents a high performance in terms of overall health; Functional -scale: consists of five subscales of operation: physical, role, emotional, cognitive and social; Symptoms scale consisting of a number of symptoms: fatigue, nausea, vomiting, pain, dyspnea, insomnia, decreased appetite, constipation, diarrhea and financial difficulties. A high score on each of these symptoms represents a high level of symptoms or problems in this area. The QLQ-CR29 was then developed after revising the QLQ-CR38, and was demonstrated internationally to have both sufficient validity and reliability to support its use as a supplement to the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings. The QLQ-CR29 contains 29 items, and is described in detail elsewhere. Briefly, there are 18 items addressing gastrointestinal symptoms, pain and problems with micturition, and there are separate scales for the participants with or without a stoma and separate items addressing sexual function for men and women. The response categories for each item are the same as those used in the QLQ-C30.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer | – | Other: No interventionOne cohort of patients with colorectal cancer, studied before the intervention, and one month, one year, two years, three years and five years after. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort study included patients drawn from 22 hospitals belonging to the Spanish National Health Service (SNS), which covers the majority (99.8%) of the population of Spain. All covered residents have free access to their primary care physician and to the ED of the hospitals. All of the hospitals have similar technological and human resources. Patients with a diagnosis of colon or rectum cancer attending the surgical services of any of these hospitals to undergo surgery between June 2010 and December 2012 were informed of the goals of the study and invited to voluntarily participate.
Key inclusion criteria (1 listed)
- Patients were eligible for the study if they were included in the surgical waiting list of one of the participating hospitals with a diagnosis of surgically resectable colon or rectum cancer. Colon or rectum cancer diagnosis was based on anatomopathological diagnosis after a biopsy by colonoscopy. Inclusion criteria were having diagnosed with colon cancer (up to 15 cm above the anal margin) and rectum (between the anal margin and 15 cm above it), where curative and / or palliative surgery for treatment by first time were applied and who sign the informed consent to participate in the study consent.
Key exclusion criteria (1 listed)
- Exclusion criteria were colon or rectum in situ cancer, unresectable tumor, severe mental or physical conditions which preclude the patient to respond to questionnaires, terminal patients, patients unable to respond to questionnaires from any cause or who do not give their consent to participate in the study.
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 | Other | Patients with colorectal cancer |
Primary outcome
Mortality
Time frame: up to five years
5 secondary outcomes
Number of participants with Readmission
Time frame: up to five years
Number of participants with Reintervention
Time frame: up to five years
Changes in health-related quality of life (in the questionnaires employed in the study)
Time frame: up to five years
Number of participants with Complications
Time frame: up to five years
Number of participants with Cancer recurrence
Time frame: up to five years
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 24 Aug 2016.
- Derived from this study: PubMed 36892600Orive M, Barrio I, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Cortajarena S, Bilbao A, Aguirre U, Sarasqueta C, Quintana JM; REDISSEC-CARESS/CCR group. Five-year follow-up mortality prognostic index for colorectal patients. Int J Colorectal Dis. 2023 Mar 9;38(1):64. doi: 10.1007/s00384-023-04358-0.
- Derived from this study: PubMed 35737143Orive M, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, Fernandez de Larrea N, Redondo M, Bilbao A, Sarasqueta C, Aguirre U, Quintana JM; REDISSEC-CARESS/CCR group. Anxiety, depression, health-related quality of life, and mortality among colorectal patients: 5-year follow-up. Support Care Cancer. 2022 Oct;30(10):7943-7954. doi: 10.1007/s00520-022-07177-1. Epub 2022 Jun 23.
- Derived from this study: PubMed 34893952Quintana JM, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Aguirre U, Briones E, Group FTRCR. Quality Indicators and Outcomes in a Prospective Cohort of Colorectal Cancer Patients. J Gastrointest Cancer. 2023 Mar;54(1):20-26. doi: 10.1007/s12029-021-00779-8. Epub 2021 Dec 10.
- Derived from this study: PubMed 34446044Gonzalez N, Lorono A, Aguirre U, Lazaro S, Bare M, Redondo M, Briones E, Sarasqueta C, Bilbao A, de Larrea NF, Quintana JM; REDISSEC-CARESS/CCR group. Risk scores to predict mortality 2 and 5 years after surgery for colorectal cancer in elderly patients. World J Surg Oncol. 2021 Aug 26;19(1):252. doi: 10.1186/s12957-021-02356-6.
- Derived from this study: PubMed 31485982Quintana JM, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S; REDISSEC CARESS-CCR (Results and Health Services Research in Colorectal Cancer)- group. Predictors of readmission and reoperation in patients with colorectal cancer. Support Care Cancer. 2020 May;28(5):2339-2350. doi: 10.1007/s00520-019-05050-2. Epub 2019 Sep 4.
- Derived from this study: PubMed 31140003Mar J, Anton-Ladislao A, Ibarrondo O, Arrospide A, Lazaro-Aramburu S, Gonzalez N, Bare M, Escobar A, Redondo M, Quintana JM; REDISSEC-CARESS/CCR group. Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer. Surg Endosc. 2020 Mar;34(3):1167-1176. doi: 10.1007/s00464-019-06867-y. Epub 2019 May 28.
- Derived from this study: PubMed 30793242Orive M, Aguirre U, Gonzalez N, Lazaro S, Redondo M, Bare M, Anula R, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Quintana JM; REDISSEC-CARESS/CCR group. Risk factors affecting hospital stay among patients undergoing colon cancer surgery: a prospective cohort study. Support Care Cancer. 2019 Nov;27(11):4133-4144. doi: 10.1007/s00520-019-04683-7. Epub 2019 Feb 22.
- Derived from this study: PubMed 29921557Quintana JM, Anton-Ladisla A, Gonzalez N, Lazaro S, Bare M, Fernandez de Larrea N, Redondo M, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S; REDISSEC-CARESS/CCR group. Outcomes of open versus laparoscopic surgery in patients with colon cancer. Eur J Surg Oncol. 2018 Sep;44(9):1344-1353. doi: 10.1016/j.ejso.2018.05.030. Epub 2018 Jun 6.
- Derived from this study: PubMed 29869084Mar J, Anton-Ladislao A, Ibarrondo O, Arrospide A, Lazaro S, Gonzalez N, Bare M, Callejo D, Redondo M, Quintana JM; REDISSEC-CARESS/CCR group. Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer. Surg Endosc. 2018 Dec;32(12):4912-4922. doi: 10.1007/s00464-018-6250-9. Epub 2018 Jun 4.
- Derived from this study: PubMed 29563837Arostegui I, Gonzalez N, Fernandez-de-Larrea N, Lazaro-Aramburu S, Bare M, Redondo M, Sarasqueta C, Garcia-Gutierrez S, Quintana JM; REDISSEC CARESS-CCR Group. Combining statistical techniques to predict postsurgical risk of 1-year mortality for patients with colon cancer. Clin Epidemiol. 2018 Mar 6;10:235-251. doi: 10.2147/CLEP.S146729. eCollection 2018.
- Derived from this study: PubMed 29378647Bare M, Alcantara MJ, Gil MJ, Collera P, Pont M, Escobar A, Sarasqueta C, Redondo M, Briones E, Dujovne P, Quintana JM; CARESS-CCR Study Group. Validity of the CR-POSSUM model in surgery for colorectal cancer in Spain (CCR-CARESS study) and comparison with other models to predict operative mortality. BMC Health Serv Res. 2018 Jan 29;18(1):49. doi: 10.1186/s12913-018-2839-x.
- Derived from this study: PubMed 27391216Quintana JM, Gonzalez N, Anton-Ladislao A, Redondo M, Bare M, Fernandez de Larrea N, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Aguirre U; REDISSEC-CARESS/CCR group. Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project. BMC Cancer. 2016 Jul 8;16:435. doi: 10.1186/s12885-016-2475-y.
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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.
Jose M Quintana, PhD principal investigator
Hospital Galdakao-Usansolo
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hospital Galdakao-Usansolo.
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 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488161, which also lists 12 linked publications.
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 24 Aug 2016.