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NCT Number: NCT01321658

Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of gastrointestinal surgery, Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Geriatric intervention

Other

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.

Primary outcomes

  1. Postoperative complications

    Time frame: 30 days after surgery

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Cancer Society
  • University Hospital, Akershus

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2011
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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