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

NCT03904121 | Completed DMC

• 1 other identifier: R19028
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

Colon cancer surgery octogenarian postoperative outcome

Outcome Measures

Primary Outcomes (2)

• Postoperative morbidity

  Clavien-Dindo classification (0-V)

  30 days

• Postoperative mortality

  Date of death

  12 months

Secondary Outcomes (1)

• Functional performance

  12 months

Interventions

Curative operation PROCEDURE

Postoperative morbidity, mortality, functional outcome, survival

Also known as: Palliative operation, Non-operative treatment

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary colon cancer patients (stage I-III) in the aged over 80 years

You may qualify if:

• primary colon cancer, which is surgically treated with curative intent (stage I-III)

You may not qualify if:

• metastatic colon cancer, severe dementia, life expectancy less than six months

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University

Tampere, 33100, Finland

Location

Related Publications (1)

• Niemelainen S, Huhtala H, Ehrlich A, Kossi J, Jamsen E, Hyoty M. Surgical and functional outcomes and survival following Colon Cancer surgery in the aged: a study protocol for a prospective, observational multicentre study. BMC Cancer. 2021 Jun 14;21(1):698. doi: 10.1186/s12885-021-08454-8.

  PMID: 34126949 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Marja Hyöty, M.D.,Ph.D.

  Tampere UH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Surgery

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)