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Trial record 35 of 5040 for:    colon cancer

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
Sponsor:
Information provided by (Responsible Party):
Susanna Niemeläinen, Tampere University Hospital

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 performance, mortality and overall survival.


Condition or disease Intervention/treatment
Colon Cancer Procedure: Curative operation

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Procedure: Curative operation
    Postoperative morbidity, mortality, functional outcome, survival
    Other Names:
    • Palliative operation
    • Non-operative treatment


Primary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: 30 days ]
    Clavien-Dindo classification (0-V)

  2. Postoperative mortality [ Time Frame: 12 months ]
    Date of death


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary colon cancer patients (stage I-III) in the aged over 80 years
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

Information from the National Library of Medicine

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


Contacts
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Contact: SUSANNA NIEMELÄINEN, M.D. +358444858116 susanna.niemelainen@gmail.com

Locations
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Finland
Tampere University Recruiting
Tampere, Finland, 33100
Contact: SUSANNA NIEMELÄINEN, M.D.    +358405415757    susanna.niemelainen@gmail.com   
Contact: Marja Hyöty, M.D.,Ph.D.    +358331167678    marja.hyoty@pshp.fi   
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         
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Study Director: Marja Hyöty, M.D.,Ph.D. Tampere UH

Additional Information:

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Responsible Party: Susanna Niemeläinen, Chief Physician of Surgery, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03904121     History of Changes
Other Study ID Numbers: R19028
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susanna Niemeläinen, Tampere University Hospital:
Colon cancer surgery octogenarian postoperative outcome

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases