Colorectal CancerNCT02352688
RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care
A study testing Enhanced Colorectal Geriatric Care in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Enhanced Colorectal Geriatric Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Enhanced Colorectal Geriatric Care
- Keywords
- elderly, enhanced recovery after surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Colorectal Geriatric CareProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Colorectal Geriatric Care | Active comparator | Multidisciplinary team involving in the elderly colorectal cancer patients' pre-, peri- and postoperative care. Receives: Procedure: Enhanced Colorectal Geriatric Care |
| Standard Surgical Care | No intervention | Standard care given to elderly patients undergoing colorectal cancer resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
Measured: up to 90 days
Secondary outcomes (2)
30-day morbidity
Measured: 30 day from time of surgery
30-day mortality
Measured: 30 day from time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Wing Chung Mak, Chinese University of Hong Kong
- Investigators
- Tony Mak, MD, Principal investigator, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352688
- Sponsor's protocol ID
- CRE-2014.550-T
- Status last verified
- Jul 2017
- First submitted
- 19 Jan 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on Preoperative Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Input
- ClinicalTrials.gov ID
- NCT02352688
- Acronym / sponsor ID
- CRE-2014.550-T
- Conditions
- Colorectal Cancer
- Keywords
- elderly, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Colorectal Geriatric Care | Active comparator | Procedure: Enhanced Colorectal Geriatric CareMultidisciplinary team involving in the elderly colorectal cancer patients' pre-, peri- and postoperative care. |
| Standard Surgical Care | No intervention | –Standard care given to elderly patients undergoing colorectal cancer resection. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Colorectal Geriatric Care | Procedure or surgery | Enhanced Colorectal Geriatric Care |
Primary outcome
Length of postoperative hospital stay
Time frame: up to 90 days
2 secondary outcomes
30-day morbidity
Time frame: 30 day from time of surgery
30-day mortality
Time frame: 30 day from time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Mak, MD principal investigator
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Colorectal Geriatric Care in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of postoperative hospital stay (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.