MedDataX Logo

Predictors of One-Year Mortality After Curative Surgery in Patients Aged 80 Years or Older With Non-Metastatic Colorectal Cancer

NCT ID: NCT06704646

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Curative intent surgery means that surgeons intend to perform R0 resection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Curative intent surgery

Curative intent surgery means that surgeons intend to perform R0 resection.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31455888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37395836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21445672 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202003045RINB

Identifier Type: -

Identifier Source: org_study_id