RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care

July 18, 2017 updated by: Tony Wing Chung Mak, Chinese University of Hong Kong

A Randomised Controlled Trial on Preoperative Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Input

This study evaluates the effects of enhanced geriatric input on elderly patients undergoing colorectal cancer surgery. Half of the participants will received additional pre, peri and post-operative care from the geriatric team, while the other half will receive standard surgical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Additional geriatric care involves appropriate assessments and interventions by a multidisciplinary team involving geriatricians, physiotherapist, occupational therapist, surgical team, dietician and social worker. It is divided into three stages of care: 1) preoperative assessment, 2) perioperative care and 3) discharge or rehabilitation. In preoperative assessment, a comprehensive geriatric assessment will be carried out which encompasses patients medical and social backgrounds, cognitive status, nutritional assessment and risk factors identification. Perioperative care includes a joint care by surgical and geriatric teams aiming to prevent and treat any postoperative complications. Discharge and rehabilitation aim to identifies and facilities any potential discharge problem or accelerates patients for rehabilitation to the appropriate locations.

Standard surgical care will be given to patients who are undergoing colorectal cancer surgery but without the additional input mentioned above.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
  2. American Society of Anaesthesiologists fitness score of I, II or III

Exclusion Criteria:

  1. Colorectal cancer patients aged 69 or under undergoing colorectal surgery
  2. Patients undergoing emergency colorectal cancer resection
  3. Patients with benign pathology
  4. Patients with evidence of locally advanced or metastatic spread of their primary disease
  5. Patient who are unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Enhanced Colorectal Geriatric Care
Multidisciplinary team involving in the elderly colorectal cancer patients' pre-, peri- and postoperative care.
Procedure: Enhanced Colorectal Geriatric Care
NO_INTERVENTION: Standard Surgical Care
Standard care given to elderly patients undergoing colorectal cancer resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of postoperative hospital stay
Time Frame: up to 90 days
up to 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day morbidity
Time Frame: 30 day from time of surgery
30 day from time of surgery
30-day mortality
Time Frame: 30 day from time of surgery
30 day from time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Tony Mak, MD, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2014.550-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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