Colorectal CancerFTSNCT01969591
Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
A study testing fast-track surgery and conventional postoperative surgery in people with Colorectal Cancer, run by Quan Wang.
Trial summary
To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- fast-track surgery and conventional postoperative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Sep 2013
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≤75 years
- Good nutrition
- no systemic infection
- Elective laparoscopic surgery
Who cannot join
- Age >75 years
- Malnutrition or an organ system infection
- Associated with obstruction, bleeding, emergency surgery or surgical intervention
- Tumor with extensive metastasis
- Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
- Previous history of abdominal surgery
- Patient had previously undergone gastrostomy
About this study
To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.
Read the detailed description
Method: This study is a blinded randomized trial. 70 patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Outcome measures, length of hospital stay, postoperative surgical stress response (C reactive protein) and postoperative complications will be compared between the two groups.
- Conditions
- Colorectal Cancer
- Being tested
- fast-track surgery, conventional postoperative surgery
- Keywords
- Fast track surgery, Laparoscopic surgery, colorectal cancer
- 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 surgeryProcedure or surgery
Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
conventional postoperative surgeryOther
Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
| Study group | Role | What they receive |
|---|---|---|
| fast-track surgery | Experimental | Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Receives: Procedure: fast-track surgery |
| convontional postoperative care | Other | Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Receives: Other: conventional postoperative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: with the first 30 days(plus or minus 3days) after surgery
Postoperative days
Measured: with the first 30 days(plus or minus 3days) after surgery
First flatus time
Measured: with the first 30 days(plus or minus 3days) after surgery
First defecation time
Measured: with the first 30 days(plus or minus 3days) after surgery
solid diet time
Measured: with the first 30 days(plus or minus 3days) after surgery
Secondary outcomes (3)
Analgesics
Measured: with the first 30 days(plus or minus 3days) after surgery
CRP (mg/L)
Measured: with the first 30 days(plus or minus 3days) after surgery
Complications:anastomotic leakage,intestinal obstruction,wound infection
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionSep 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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969591
- Sponsor's protocol ID
- 2013-171
- Other IDs
- 2013-171
- Acronym
- FTS
- Status last verified
- Oct 2013
- First submitted
- 8 Oct 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01969591
- Acronym / sponsor ID
- FTS / 2013-171
- Conditions
- Colorectal Cancer
- Keywords
- Fast track surgery, Laparoscopic surgery, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Quan WangUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Oct 2013 (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.
To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.
Detailed description
Method: This study is a blinded randomized trial. 70 patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Outcome measures, length of hospital stay, postoperative surgical stress response (C reactive protein) and postoperative complications will be compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast-track surgery | Experimental | Procedure: fast-track surgeryPatients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. |
| convontional postoperative care | Other | Other: conventional postoperative surgeryPatients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≤75 years
- Good nutrition
- no systemic infection
- Elective laparoscopic surgery
Key exclusion criteria (7 listed)
- Age >75 years
- Malnutrition or an organ system infection
- Associated with obstruction, bleeding, emergency surgery or surgical intervention
- Tumor with extensive metastasis
- Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
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 surgeryPatients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. | Procedure or surgery | fast-track surgery |
| conventional postoperative surgeryPatients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. | Other | convontional postoperative care |
Primary outcome
Length of hospital stay
Time frame: with the first 30 days(plus or minus 3days) after surgery
Postoperative days
Time frame: with the first 30 days(plus or minus 3days) after surgery
First flatus time
Time frame: with the first 30 days(plus or minus 3days) after surgery
First defecation time
Time frame: with the first 30 days(plus or minus 3days) after surgery
solid diet time
Time frame: with the first 30 days(plus or minus 3days) after surgery
3 secondary outcomes
Analgesics
Time frame: with the first 30 days(plus or minus 3days) after surgery
CRP (mg/L)
Time frame: with the first 30 days(plus or minus 3days) after surgery
Complications:anastomotic leakage,intestinal obstruction,wound infection
Time frame: one year
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 25 Oct 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fast-track surgery and conventional postoperative surgery in people with Colorectal Cancer, run by Quan Wang.
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 4 inclusion and 7 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 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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 hospital stay (time frame: with the first 30 days(plus or minus 3days) after surgery). The study lists 5 primary outcomes in all. 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 25 Oct 2013; AzTrials last refreshed its copy on 4 Nov 2026.