Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 21, 2015
October 1, 2015
4.7 years
March 18, 2011
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complications
30 days after surgery
Secondary Outcomes (6)
Reoperation
30 days after surgery
Readmission
30 days after surgery
Length of hospital stay
30 days after surgery
Survival
3 months after surgery
Quality of life
3 months after surgery
- +1 more secondary outcomes
Study Arms (2)
Geriatric intervention
EXPERIMENTALControl
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Age 65+
- Elective surgery for colorectal cancer
- Frail
You may not qualify if:
- Acute surgery
- Not able to consent
- Does not consent with registration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Norwegian Cancer Societycollaborator
- University Hospital, Akershuscollaborator
Study Sites (1)
Dept of gastrointestinal surgery, Oslo University Hospital
Oslo, 0424, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Torgeir B Wyller, Dr.med
Geriatric dept., Oslo University hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 23, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 21, 2015
Record last verified: 2015-10