Back to resultsRCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Enhanced Colorectal Geriatric Care
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring elderly, enhanced recovery after surgery
Eligibility Criteria
Inclusion Criteria:
- Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
- American Society of Anaesthesiologists fitness score of I, II or III
Exclusion Criteria:
- Colorectal cancer patients aged 69 or under undergoing colorectal surgery
- Patients undergoing emergency colorectal cancer resection
- Patients with benign pathology
- Patients with evidence of locally advanced or metastatic spread of their primary disease
- Patient who are unable to give informed consent
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Enhanced Colorectal Geriatric Care
Standard Surgical Care
Arm Description
Multidisciplinary team involving in the elderly colorectal cancer patients' pre-, peri- and postoperative care.
Standard care given to elderly patients undergoing colorectal cancer resection.
Outcomes
Primary Outcome Measures
Length of postoperative hospital stay
Secondary Outcome Measures
30-day morbidity
30-day mortality
Full Information
NCT ID
NCT02352688
First Posted
January 19, 2015
Last Updated
July 18, 2017
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02352688
Brief Title
RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care
Official Title
A Randomised Controlled Trial on Preoperative Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Input
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
elderly, enhanced recovery after surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Colorectal Geriatric Care
Arm Type
Active Comparator
Arm Description
Multidisciplinary team involving in the elderly colorectal cancer patients' pre-, peri- and postoperative care.
Arm Title
Standard Surgical Care
Arm Type
No Intervention
Arm Description
Standard care given to elderly patients undergoing colorectal cancer resection.
Intervention Type
Procedure
Intervention Name(s)
Enhanced Colorectal Geriatric Care
Primary Outcome Measure Information:
Title
Length of postoperative hospital stay
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
30-day morbidity
Time Frame
30 day from time of surgery
Title
30-day mortality
Time Frame
30 day from time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
American Society of Anaesthesiologists fitness score of I, II or III
Exclusion Criteria:
Colorectal cancer patients aged 69 or under undergoing colorectal surgery
Patients undergoing emergency colorectal cancer resection
Patients with benign pathology
Patients with evidence of locally advanced or metastatic spread of their primary disease
Patient who are unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Mak, MD
Organizational Affiliation
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care
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