Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Other: Geriatric intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65+ Elective surgery for colorectal cancer Frail Exclusion Criteria: Acute surgery Not able to consent Does not consent with registration

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geriatric intervention<br> | Other: Geriatric intervention<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | Number of patients in need of any operation within thirty days after the operation for colorectal cancer. | 30 days after surgery | 
| Readmission | Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery. | 30 days after surgery | 
| Length of hospital stay |  | 30 days after surgery | 
| Survival |  | 3 months after surgery | 
| Quality of life |  | 3 months after surgery | 
| 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. | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatric Assessment, Perioperative Care, Colorectal Neoplasms, Frail Elderly