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Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Norwegian Cancer Society
University Hospital, Akershus
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01321658
First received: March 18, 2011
Last updated: March 24, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
 Other: Geriatric intervention

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Postoperative complications [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute surgery
  • Not able to consent
  • Does not consent with registration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321658

Contacts
Contact: Nina Ommundsen, MD +4740225685 ninaommundsen@gmail.com
Contact: Torgeir Bruun Wyller, Dr.med +4722118702 t.b.wyller@medisin.uio.no

Locations
Norway
Dept of gastrointestinal surgery, Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Nina Ommundsen, MD     +4740225685     ninaommundsen@gmail.com    
Contact: Hans-Olaf Johannessen, dr.med         uxhojo@ous-hf.no    
Principal Investigator: Nina Ommundsen, MD            
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
University Hospital, Akershus
Investigators
Study Chair: Torgeir B Wyller, Dr.med Geriatric dept., Oslo University hospital
  More Information

No publications provided

Responsible Party: Professor Torgeir Bruun Wyller, Dept of geriatric medicine, Oslo University hospital
ClinicalTrials.gov Identifier: NCT01321658     History of Changes
Other Study ID Numbers: 2010/1634
Study First Received: March 18, 2011
Last Updated: March 24, 2011
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Geriatric Assessment
Perioperative Care
Colorectal Neoplasms
Frail Elderly

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 21, 2013