Colon Cancer Surgery in the Aged; Postoperative Outcome,... | NCT03904121

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

NCT03904121

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Apr 12, 2022Actual

Enrollment

262Actual

Phase

Not provided

Conditions

Colon Cancer

Interventions

Curative operation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Mar 31, 2022Actual

First Submitted Date

Apr 1, 2019

First Submission Date that Met QC Criteria

Apr 3, 2019

First Posted Date

Apr 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2022

Last Update Posted Date

Apr 12, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susanna Niemeläinen, Chief Physician of Surgery, Tampere University HospitalPrincipal Investigator

Lead Sponsor

Tampere University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

9 Finnish hospitals including three university hospitals participate in the study. The data is collected from the hospitals using a specially designed and secure web application (RedCap).

The preoperative patients' data include comorbidities, clinical frailty scale (CFS) and functional status, postoperative surgical and medical outcomes and survival data. The patient questionnaire is based on the G-8 geriatric screening tool and MNA-short form. 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 aged over 80 years with curative disease (stage I-III) are included. Patients with metastatic disease or severe Alzheimer 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 committee of the participating hospitals.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

262Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curative operation	Procedure	Postoperative morbidity, mortality, functional outcome, survival		Palliative operation Non-operative treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative morbidity	Clavien-Dindo classification (0-V)	30 days
Postoperative mortality	Date of death	12 months

Secondary Outcomes

Measure	Description	Time Frame
Functional performance	Patient questionnaire ( nutritional status, mobility, use of implements, medication, weight, housing, homeaid), scale 0-3; 0= no, 1= sometimes, 2= often, 3= always	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marja Hyöty, M.D.,Ph.D.	Tampere UH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University		Tampere		33100	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34126949	Derived	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.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms