Back to resultsGeriatric Intervention in Frail Elderly Patients With Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Geriatric intervention
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Geriatric Assessment, Perioperative Care, Colorectal Neoplasms, Frail Elderly
Eligibility Criteria
Inclusion Criteria:
- Age 65+
- Elective surgery for colorectal cancer
- Frail
Exclusion Criteria:
- Acute surgery
- Not able to consent
- Does not consent with registration
Sites / Locations
- Dept of gastrointestinal surgery, Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Geriatric intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Postoperative complications
Secondary Outcome Measures
Reoperation
Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
Readmission
Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
Length of hospital stay
Survival
Quality of life
Living at home or in institution
Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.
Full Information
NCT ID
NCT01321658
First Posted
March 18, 2011
Last Updated
October 20, 2015
Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society, University Hospital, Akershus
1. Study Identification
Unique Protocol Identification Number
NCT01321658
Brief Title
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
Official Title
Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society, University Hospital, Akershus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.
The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Geriatric Assessment, Perioperative Care, Colorectal Neoplasms, Frail Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Geriatric intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Geriatric intervention
Intervention Description
A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.
Primary Outcome Measure Information:
Title
Postoperative complications
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Reoperation
Description
Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
Time Frame
30 days after surgery
Title
Readmission
Description
Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
Time Frame
30 days after surgery
Title
Length of hospital stay
Time Frame
30 days after surgery
Title
Survival
Time Frame
3 months after surgery
Title
Quality of life
Time Frame
3 months after surgery
Title
Living at home or in institution
Description
Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65+
Elective surgery for colorectal cancer
Frail
Exclusion Criteria:
Acute surgery
Not able to consent
Does not consent with registration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir B Wyller, Dr.med
Organizational Affiliation
Geriatric dept., Oslo University hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of gastrointestinal surgery, Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
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