Predicting function and quality-of-life decline after curative surgery for gastrointestinal cancer in people over 65
Predictive Factors Associated With Functional Decline and Quality of Life Decline at 12 Months Follow-up and 5 Year Oncological Follow-up in Patients >65 Yares With a Gastrointestinal Tract Cancer Diagnosis Taken to Resectable Surgery With a Curative Intent in Hospital Universitario Mayor-Méderi, Bogotá, Colombia
This project will try to see which pre- and perioperative factors predict loss of independence and worse quality of life over one year in people aged 65 and older who have curative surgery for gastrointestinal cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 327 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Mayor Méderi Academic / other |
| Locations | 1 site (Bogotá) |
| Trial ID | NCT07412379 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of patients aged 65 and older with resectable gastrointestinal tract cancers who undergo curative-intent surgery at Hospital Universitario Mayor-Méderi. Investigators will record baseline geriatric measures (functional status, Katz score, markers of sarcopenia, comorbidities) and quality-of-life scores, then follow participants for functional and quality-of-life outcomes at 12 months and oncologic outcomes up to five years. Patients undergoing emergency surgery, not taken to surgery, or with baseline complete dependence are excluded. Statistical analysis will identify preoperative and perioperative predictors of decline to inform risk stratification and patient management.
Who should consider this trial
Good fit: People aged 65 or older with a resectable gastrointestinal tract cancer who are taken to curative-intent surgery at Hospital Universitario Mayor-Méderi and can give informed consent are ideal candidates.
Not a fit: Patients not undergoing planned curative surgery (including emergency operations), those with baseline total dependence (Katz 0/6), recent other primary cancers without a 5-year disease-free interval, those lost to follow-up, or treated outside the Mederi network are unlikely to benefit from the study's predictive findings.
Why it matters
Potential benefit: If successful, the results could help clinicians identify older patients at high risk for losing independence after cancer surgery so they can target prehabilitation, enhanced monitoring, or supportive services to preserve function and quality of life.
How similar studies have performed: Previous studies have linked frailty, sarcopenia, and comorbidity to poorer postoperative recovery and quality-of-life outcomes in older cancer patients, but predictive models differ and long-term single-center prognostic data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bogotá
- Hospital Universitario Mayor-Méderi — Bogotá, Colombia (Recruiting)
Study contacts
- Study coordinator: Camilo Ramírez-Giraldo, Surgeon
- Email: ramirezgiraldocamilo@gmail.com
- Phone: 3206770474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.