Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Other: Geriatric intervention

• Registration Number: NCT01321658
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Age 65+
• Elective surgery for colorectal cancer
• Frail

Exclusion Criteria

• Acute surgery
• Not able to consent
• Does not consent with registration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric intervention	Geriatric intervention	-

Primary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	30 days after surgery
Survival	3 months after surgery
Reoperation	30 days after surgery	Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
Quality of life	3 months after surgery
Readmission	30 days after surgery	Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
Living at home or in institution	3 months after surgery	Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.

Trial Locations

Locations (1)

Dept of gastrointestinal surgery, Oslo University Hospital; 🇳🇴 Oslo, Norway