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NCT07412379
Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults
Conditions: Cancer Abdomen, Elderly (People Aged 65 or More), Quality of Life, Sarcopenia in Elderly, Functional Autonomy Level
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Enrollment: 590
Sponsor: Hospital Universitario Mayor Méderi
Location: Hospital Universitario Mayor-Méderi Bogotá
Summary
This prospective cohort study will evaluate functional decline, health-related quality of life, and long-term oncological outcomes in adults aged 65 years and older undergoing curative-intent resective surgery for gastrointestinal cancer at Hospital Universitario Mayor-Méderi in Bogotá, Colombia.
The primary objectives are to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life at 12 months after surgery. Functional decline will be assessed using the Katz Index of Independence in Activities of Daily Living, and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Long-term oncological outcomes will include overall survival, time to recurrence, and disease-free survival, with estimates reported at 1, 3, and 5 years after surgery.
Participants will undergo standardized preoperative assessment of demographic, oncological, functional, frailty, nutritional, cognitive, psychological, and sarcopenia-related factors. Multivariable prognostic models will be developed to evaluate their association with the primary outcomes.
Eligibility Criteria
Inclusion Criteria:
* Gastrointestinal cancer tract diagnosis (oesophagus, stomach, duodenum, pancreas, liver, biliary tract, small bowel, appendix, colon and rectum)
* Have resectable disease by surgery
* Taken to surgery by curative intent
* Willingness to participate and enrollment by informed consent
* Attended in the Mederi Hospital Networn
Exclusion Criteria:
* Mortality
* Loss to follow-up
* Not taken to surgery
* Emergency surgery
* Taken to surgery as an oncological relapse or due to complications previous to an index procedure
* Endoscopical treatment
* Second primary tumor without a minimum 5 year disease free period from the primary one
* Basal functionality 0/6 by Katz score.
Source: ClinicalTrials.gov (NCT07412379). StuddyBuddy aggregates publicly available trial information.