Colon Cancer Surgery in the Aged; Postoperative Functional Ability, Quality of Life and Survival
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|ClinicalTrials.gov Identifier: NCT03904121|
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : May 21, 2019
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 performance, mortality and overall survival.
|Condition or disease||Intervention/treatment|
|Colon Cancer||Procedure: Curative operation|
14 Finnish hospitals including five university hospitals participate in the study. The data is collected from the hospitals using specially designed and secure web application (RedCap).
The preoperative patients data includes comorbidities, functional status, postoperative surgical and medical outcomes and survival data. The patient questionnaire is based to G-8 geriatric screening tool and clinical frailty scale (CFS)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 in aged over 80 years with curative disease (stage I-III) are included. Patients with metastatic disease or severe altzheimer 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 commitees of the participating hospitals.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Colon Cancer Surgery in the Aged; Postoperative Functional Ability, Quality of Life and Survival|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Procedure: Curative operation
Postoperative morbidity, mortality, functional outcome, survivalOther Names:
- Palliative operation
- Non-operative treatment
- Postoperative morbidity [ Time Frame: 30 days ]Clavien-Dindo classification (0-V)
- Postoperative mortality [ Time Frame: 12 months ]Date of death
- Functional performance [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904121
|Contact: SUSANNA NIEMELÄINEN, M.D.||+firstname.lastname@example.org|
|Tampere, Finland, 33100|
|Contact: SUSANNA NIEMELÄINEN, M.D. +358405415757 email@example.com|
|Contact: Marja Hyöty, M.D.,Ph.D. +358331167678 firstname.lastname@example.org|
|Principal Investigator: Susanna NIEMELÄINEN, M.D.|
|Sub-Investigator: Marja Hyöty, M.D.,Ph.D|
|Sub-Investigator: Jyrki Kössi, M.D.,Ph.D|
|Sub-Investigator: Esa Jämsen, Professor|
|Study Director:||Marja Hyöty, M.D.,Ph.D.||Tampere UH|