Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.|
- Postoperative complications [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
- Reoperation [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
- Readmission [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
- Length of hospital stay [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
- Living at home or in institution [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.
|Study Start Date:||February 2011|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Experimental: Geriatric intervention||
Other: Geriatric intervention
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.
|No Intervention: Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321658
|Contact: Nina Ommundsen, MDfirstname.lastname@example.org|
|Contact: Torgeir Bruun Wyller, Dr.email@example.com|
|Dept of gastrointestinal surgery, Oslo University Hospital||Recruiting|
|Oslo, Norway, 0424|
|Contact: Nina Ommundsen, MD +4740225685 firstname.lastname@example.org|
|Contact: Hans-Olaf Johannessen, dr.med email@example.com|
|Principal Investigator: Nina Ommundsen, MD|
|Study Chair:||Torgeir B Wyller, Dr.med||Geriatric dept., Oslo University hospital|