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.

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

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.

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