Clinical trial NCT03904121: Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival.
Official title: Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Colon cancer surgery octogenarian postoperative outcome
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 262
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary colon cancer patients (stage I-III) in the aged over 80 years

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days
measure: Postoperative mortality
timeFrame: 12 months
Secondary outcomes:
measure: Functional performance
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University
Study officials:
affiliation: Tampere UH
name: Marja Hyöty, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
citation: Niemelainen S, Huhtala H, Ehrlich A, Kossi J, Jamsen E, Hyoty M. Surgical and functional outcomes and survival following Colon Cancer surgery in the aged: a study protocol for a prospective, observational multicentre study. BMC Cancer. 2021 Jun 14;21(1):698. doi: 10.1186/s12885-021-08454-8.