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

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: Colorectal Cancer
• Intervention / Treatment: Procedure: Enhanced Colorectal Geriatric 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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	up to 90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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: elderly; enhanced recovery after surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRE-2014.550-T