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Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival.

Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03904121
Enrollment
262
Registered
2019-04-04
Start date
2019-04-01
Completion date
2022-03-31
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Colon cancer surgery octogenarian postoperative outcome

Brief summary

Patients aged \> 80 years represent an increasing proportion of colon cancer diagnoses. It is important to have relevant and trustable data concerning elderly colorectal cancer patients surgery and postoperative morbidity, functional ability, life quality and survival numbers. With possibly compromised health status and functional decline the benefits of surgical management and outcomes can diminish life quality and overall survival. With proper patients selection, preoperative health evaluation and thus patient information, colorectal cancer surgery can be performed with lower morbidity and mortality rates with comparative survival numbers. The aim of this prospectively collected, observational study is to acquire data from colorectal cancer surgery in aged over 80 years and perform statistical analysis of the preoperative risk factors affecting postoperative morbidity, functional recovery, mortality and overall survival.

Detailed description

9 Finnish hospitals including three university hospitals participate in the study. The data is collected from the hospitals using a specially designed and secure web application (RedCap). The preoperative patients' data include comorbidities, clinical frailty scale (CFS) and functional status, postoperative surgical and medical outcomes and survival data. The patient questionnaire is based on the G-8 geriatric screening tool and MNA-short form. The questionnaire is filled out preoperatively and 1, 3, 6 and 12 months postoperatively. The patient data concerning procedures is collected from the hospitals prospectively recording data. Mortality data on causes of death are obtained from Statistics Finland. All colon cancer patients aged over 80 years with curative disease (stage I-III) are included. Patients with metastatic disease or severe Alzheimer disease are excluded. They are treated either non-operatively or with curative resection or palliative procedure. Patients fill out the approval form. The study is acknowledged by the ethics committee of the participating hospitals.

Interventions

PROCEDURECurative operation

Postoperative morbidity, mortality, functional outcome, survival

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* primary colon cancer, which is surgically treated with curative intent (stage I-III)

Exclusion criteria

* metastatic colon cancer, severe dementia, life expectancy less than six months

Design outcomes

Primary

MeasureTime frameDescription
Postoperative morbidity30 daysClavien-Dindo classification (0-V)
Postoperative mortality12 monthsDate of death

Secondary

MeasureTime frameDescription
Functional performance12 monthsPatient questionnaire ( nutritional status, mobility, use of implements, medication, weight, housing, homeaid), scale 0-3; 0= no, 1= sometimes, 2= often, 3= always

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026