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Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01321658
Enrollment
122
Registered
2011-03-23
Start date
2011-02-28
Completion date
2015-10-31
Last updated
2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Geriatric Assessment, Perioperative Care, Colorectal Neoplasms, Frail Elderly

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.

Interventions

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.

Sponsors

Norwegian Cancer Society
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Postoperative complications30 days after surgery

Secondary

MeasureTime frameDescription
Readmission30 days after surgeryNumber of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
Length of hospital stay30 days after surgery
Reoperation30 days after surgeryNumber of patients in need of any operation within thirty days after the operation for colorectal cancer.
Quality of life3 months after surgery
Living at home or in institution3 months after surgeryNumber of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.
Survival3 months after surgery

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026