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

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03904121
Collaborator
(none)
262
1
36
7.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Curative operation

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
262 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Colon Cancer Surgery in the Aged; Postoperative Outcome, Functional Recovery and Survival
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Postoperative morbidity [30 days]

    Clavien-Dindo classification (0-V)

  2. Postoperative mortality [12 months]

    Date of death

Secondary Outcome Measures

  1. Functional performance [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
80 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tampere University Tampere Finland 33100

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

  • Study Director: Marja Hyöty, M.D.,Ph.D., Tampere UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susanna Niemeläinen, Chief Physician of Surgery, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT03904121
Other Study ID Numbers:
  • R19028
First Posted:
Apr 4, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Susanna Niemeläinen, Chief Physician of Surgery, Tampere University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022