Colon Cancer Surgery in the Aged; Postoperative Functional Ability, Quality of Life and Survival

• ClinicalTrials.gov Identifier: NCT03904121
• Recruitment Status: Recruiting
• First Posted: April 4, 2019
• Last Update Posted: May 21, 2019
• Sponsor: Tampere University Hospital
• 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

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

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