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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

Tracking Information
First Submitted Date April 1, 2019
First Posted Date April 4, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date April 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2019)
  • Postoperative morbidity [ Time Frame: 30 days ]
    Clavien-Dindo classification (0-V)
  • Postoperative mortality [ Time Frame: 12 months ]
    Date of death
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03904121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 19, 2019)
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
Original Secondary Outcome Measures
 (submitted: April 3, 2019)
Functional performance [ Time Frame: 12 months ]
Patient questionnaire ( nutritional status, mobility, use of implements, medication, weight, housing, homeaid), scale 0-3
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Colon Cancer Surgery in the Aged; Postoperative Functional Ability, Quality of Life and Survival
Official Title Colon Cancer Surgery in the Aged; Postoperative Functional Ability, Quality of Life and Survival
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.

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary colon cancer patients (stage I-III) in the aged over 80 years
Condition Colon Cancer
Intervention Procedure: Curative operation
Postoperative morbidity, mortality, functional outcome, survival
Other Names:
  • Palliative operation
  • Non-operative treatment
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 3, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 80 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: SUSANNA NIEMELÄINEN, M.D. +358444858116 susanna.niemelainen@gmail.com
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03904121
Other Study ID Numbers R19028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Susanna Niemeläinen, Tampere University Hospital
Study Sponsor Tampere University Hospital
Collaborators Not Provided
Investigators
Study Director: Marja Hyöty, M.D.,Ph.D. Tampere UH
PRS Account Tampere University Hospital
Verification Date May 2019