- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704646
Predictors of One-Year Mortality After Curative Surgery in Patients Aged 80 Years or Older With Non-Metastatic Colorectal Cancer
November 26, 2024 updated by: National Taiwan University Hospital
The aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer is common among older adults, and with the aging global population, the number of elderly individuals diagnosed with this condition continues to rise.
Current treatment guidelines identify surgery as the primary approach for managing non-metastatic colorectal cancer.
Previous studies have shown that factors like advanced age, frailty, comorbidities, and nutritional status can predict surgical outcomes.
However, in patients over 80 years old with non-metastatic colorectal cancer, questions remain regarding the definition of advanced age and frailty, the applicability of existing assessment tools to this specific group, and the determination of optimal cut-off values, all of which require further validation.
Furthermore, there is a shortage of effective outpatient screening tools to identify vulnerable patients and provide reliable guidance for predicting postoperative survival.
Therefore, the aim of this study is to determine which preoperative factors are associated with one-year postoperative mortality in patients aged ≥80 years undergoing curative surgery and compare outcomes between patients with or without risk factors.
Study Type
Observational
Enrollment (Actual)
310
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
This retrospective study was performed at National Taiwan University hospital.
Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019, and they were followed up until December 31, 2020.
Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study.
Description
Inclusion Criteria:
Patients aged ≥80 years with stages I-III colorectal cancer who underwent tumor resection from January 2014 to January 2019
Exclusion Criteria:
Patients undergoing procedure without colectomy, or tumor excised by transanal method were excluded from this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients passed away within one year
Records their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index.
We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging
|
Curative intent surgery means that surgeons intend to perform R0 resection.
|
|
Patient survived the first post-operative year
Records their age, gender, preoperative comorbidities, and calculated their Charlson comorbidity index.
We also collected information on tumor location, serum levels of carcinoembryonic antigen (CEA), preoperative clinical TNM staging, and postoperative pathological TNM staging
|
Curative intent surgery means that surgeons intend to perform R0 resection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative factors associated with one-year postoperative mortality
Time Frame: From operation to one year after the surgery
|
Univariate and multivariable logistic regression analysis were performed to identify preoperative factors associated with one-year postoperative mortality.
|
From operation to one year after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27.
- Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.
- Chen B, Yu W, Ma Y, Xu P, Yao Q, Sun Q, Ren J, Wang D. Evaluation of the safety and efficacy of perform enterectomy in colorectal cancer patients aged 80 or older. A meta-analysis and a systematic review. Int J Colorectal Dis. 2023 Jul 3;38(1):185. doi: 10.1007/s00384-023-04461-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
November 21, 2024
First Submitted That Met QC Criteria
November 21, 2024
First Posted (Actual)
November 26, 2024
Study Record Updates
Last Update Posted (Estimated)
November 27, 2024
Last Update Submitted That Met QC Criteria
November 26, 2024
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202003045RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.