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Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01321658
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : October 21, 2015
Sponsor:
Collaborators:
Norwegian Cancer Society
University Hospital, Akershus
Information provided by (Responsible Party):
Torgeir Bruun Wyller, Oslo University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Other: Geriatric intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.
Study Start Date : February 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days after surgery ]

Secondary Outcome Measures :
  1. Reoperation [ Time Frame: 30 days after surgery ]
    Number of patients in need of any operation within thirty days after the operation for colorectal cancer.

  2. Readmission [ Time Frame: 30 days after surgery ]
    Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.

  3. Length of hospital stay [ Time Frame: 30 days after surgery ]
  4. Survival [ Time Frame: 3 months after surgery ]
  5. Quality of life [ Time Frame: 3 months after surgery ]
  6. Living at home or in institution [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321658


Locations
Norway
Dept of gastrointestinal surgery, Oslo University Hospital
Oslo, Norway, 0424
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Torgeir Bruun Wyller, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01321658     History of Changes
Other Study ID Numbers: 2010/1634
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by Torgeir Bruun Wyller, Oslo University Hospital:
Geriatric Assessment
Perioperative Care
Colorectal Neoplasms
Frail Elderly

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