Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352688
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tony Wing Chung Mak, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Enhanced Colorectal Geriatric Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial on Preoperative Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Input
Study Start Date : May 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Length of postoperative hospital stay [ Time Frame: up to 90 days ]

Secondary Outcome Measures :
  1. 30-day morbidity [ Time Frame: 30 day from time of surgery ]
  2. 30-day mortality [ Time Frame: 30 day from time of surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02352688


Locations
Layout table for location information
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Tony Mak, MD Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China
Layout table for additonal information
Responsible Party: Tony Wing Chung Mak, Assistant Professor in Colorectal Surgery, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02352688    
Other Study ID Numbers: CRE-2014.550-T
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Tony Wing Chung Mak, Chinese University of Hong Kong:
elderly
enhanced recovery after surgery
Additional relevant MeSH terms:
Layout table for 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