Clinical trial NCT06704646: Predictors of One-Year Mortality After Curative Surgery in Patients Aged 80 Years or Older With Non-Metastatic Colorectal Cancer
Official title: Predictors of One-Year Mortality After Curative Surgery in Patients Aged 80 Years or Older With Non-Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Geriatrics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 310
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Preoperative factors associated with one-year postoperative mortality
timeFrame: From operation to one year after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.