Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321658
• Other study ID #: 2010/1634
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: October 20, 2015
• Start date: February 2011
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

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.

Locations

Country	Name	City	State
Norway	Dept of gastrointestinal surgery, Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Cancer Society, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications		30 days after surgery	No
Secondary	Reoperation	Number of patients in need of any operation within thirty days after the operation for colorectal cancer.	30 days after surgery	No
Secondary	Readmission	Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.	30 days after surgery	No
Secondary	Length of hospital stay		30 days after surgery	No
Secondary	Survival		3 months after surgery	No
Secondary	Quality of life		3 months after surgery	No
Secondary	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	No