Colorectal CancerPhase 3NCT01341366
Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
A Phase 3 study testing Fast-track perioperative program and Traditional perioperative program in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Background: Laparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fast-track perioperative program and Traditional perioperative program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer,
- Age of patients between 18 and 75 years
- Patients with American Society of Anesthesiologists grading I-II
- Patients with no severe physical disability
- Patients who require no assistance with the activities of daily living
- Informed consent available
Who cannot join
- Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy
- Patients with planned stoma creation
- Patients undergoing emergency surgery
- Patients with known metastatic disease
- Patients with previous history of abdominal surgery
- Patients with known immunological dysfunction
- Patients who are taking steroids or immunosuppressive agents
- Patients with chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Laparoscopic Colorectal Surgery in Hong Kong Chinese Patients: A Prospective Randomized Trial
Background:
Laparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been introduced in the West to optimize perioperative factors to reduce the physiological/psychological stress of open colorectal surgery. However, few studies have evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal surgery.
Read more
Objective:
To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track" perioperative program.
Design:
Prospective randomized trial.
Subjects:
One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection of non-metastatic colonic and upper rectal cancer will be recruited.
Interventions:
Patients will be randomized to a "traditional" or a "fast-track" perioperative program.
Outcome measures:
Primary outcome: total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters (including systemic cytokine response and cell-mediated immune function), morbidity and mortality, quality of life, and medical costs.
- Conditions
- Colorectal Cancer
- Being tested
- Fast-track perioperative program, Traditional perioperative program
- Keywords
- Laparoscopic 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.
Fast-track perioperative programOther
Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization
Traditional perioperative programOther
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
| Study group | Role | What they receive |
|---|---|---|
| Fast-track perioperative program | Experimental | Not described Receives: Other: Fast-track perioperative program |
| Traditional perioperative program | Active comparator | Not described Receives: Other: Traditional perioperative program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
Measured: Up to 1 month
Secondary outcomes (7)
Pain scores
Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)
Measured: Up to 1 week
Morbidity and mortality
Measured: Up to 1 month
Readmission rate
Measured: Up to 1 month
Quality of life
Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
Measured: Up to 1 month
Direct/indirect medical costs and out-of-hospital economic costs
Measured: Up to 1 month
Systemic cytokine responses
Blood levels of IL-1β, IL-6, and C-reactive protein
Measured: Up to 1 week
Lymphocyte subsets
Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionMar 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341366
- Sponsor's protocol ID
- CRE-2008.552-T
- Status last verified
- Apr 2013
- First submitted
- 20 Apr 2011
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Laparoscopic Colorectal Surgery in Hong Kong Chinese Patients: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01341366
- Acronym / sponsor ID
- CRE-2008.552-T
- Conditions
- Colorectal Cancer
- Keywords
- Laparoscopic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Apr 2011 (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.
Background:
Laparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been introduced in the West to optimize perioperative factors to reduce the physiological/psychological stress of open colorectal surgery. However, few studies have evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal surgery.
Objective:
To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track" perioperative program.
Design:
Prospective randomized trial.
Subjects:
One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection of non-metastatic colonic and upper rectal cancer will be recruited.
Interventions:
Patients will be randomized to a "traditional" or a "fast-track" perioperative program.
Outcome measures:
Primary outcome: total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters (including systemic cytokine response and cell-mediated immune function), morbidity and mortality, quality of life, and medical costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track perioperative program | Experimental | Other: Fast-track perioperative program |
| Traditional perioperative program | Active comparator | Other: Traditional perioperative program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer,
- Age of patients between 18 and 75 years
- Patients with American Society of Anesthesiologists grading I-II
- Patients with no severe physical disability
- Patients who require no assistance with the activities of daily living
Key exclusion criteria (8 listed)
- Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy
- Patients with planned stoma creation
- Patients undergoing emergency surgery
- Patients with known metastatic disease
- Patients with previous history of abdominal surgery
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 |
|---|---|---|
| Fast-track perioperative programPreoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization | Other | Fast-track perioperative program |
| Traditional perioperative programPreoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon | Other | Traditional perioperative program |
Primary outcome
Duration of hospital stay
Time frame: Up to 1 month
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
7 secondary outcomes
Pain scores
Time frame: Up to 1 week
Morbidity and mortality
Time frame: Up to 1 month
Readmission rate
Time frame: Up to 1 month
Quality of life
Time frame: Up to 1 month
Direct/indirect medical costs and out-of-hospital economic costs
Time frame: Up to 1 month
Systemic cytokine responses
Time frame: Up to 1 week
Lymphocyte subsets
Time frame: Up to 1 week
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 30 Apr 2013.
- Related InfoLink provided by the sponsor.
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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.
Simon SM Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fast-track perioperative program and Traditional perioperative program in people with Colorectal Cancer, run by Chinese University of Hong Kong at 1 site in China.
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 6 inclusion and 8 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 30 Apr 2013. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of hospital stay (time frame: Up to 1 month). 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 30 Apr 2013.