Colon CancerNCT02399631
Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
A study testing Enhanced recovery program in people with Colon Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Enhanced recovery program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Dec 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility rule of enrollment
- ECOG 0-2
- Pathologically diagnosed colon cancer
- Stage I-III
- No functional disturbance in liver, kidney, bone marrow
- Informed consent
Who cannot join
- Emergent operation
- Obstructive or perforated cancer
- Rectosigmoid or rectal cancer
- Synchronous tumor
- Uncontrolled psychiatric or neurologic problems
- Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
- Renal dysfunction (Cr ≥2mg/dl)
- Recent MI, CVA, nitrate medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.
- Conditions
- Colon Cancer
- Being tested
- Enhanced recovery program
- Keywords
- Perioperative treatment, Laparoscopic surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery programOther
Enhanced recovery program day-1: no mechanical bowel preparation, intake permit until 6 hrs before operation day0: operation, postoperative fluid therapy, antibiotics day1: liquid diet, early ambulation, removal of foley catheterization day2-3: soft diet day 4-5: discharge
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | early recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery Receives: Other: Enhanced recovery program |
| Congrol group | No intervention | Traditional, conventional perioperative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration of hospital stay from the date of operation to the date when a patient meets the following "discharge criteria".
Discharge criteria:
- Tolerance of consecutive 3 soft diet
- Recovery of bowel function (without PONV)
- No necessity of intravenous analgesics
- Stable vital sign (afebrile)
Measured: 30 days post-operatively
Actual hospital stay
Measured: 30 days post-operatively
Secondary outcomes (5)
Readmission rate
Measured: 30 days from time of surgery
30-day morbidity
Measured: 30 days from time of surgery
30-day mortality
Measured: 30 days from time of surgery
Quality of life
EORTC QLQ-C30, before and after surgery
Measured: up to 30days from time of surgery
Nutritional status
Body weight, body mass index, body composition, before and after surgery
Measured: up to 30days 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 posted26 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyu-Seog Choi, Kyungpook National University Hospital
- Investigators
- Gyu-Seog Choi, MD, Study chair, Kyunpook National Univercity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399631
- Sponsor's protocol ID
- KNUHCRC005
- Status last verified
- Jan 2018
- First submitted
- 9 Mar 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT02399631
- Acronym / sponsor ID
- KNUHCRC005
- Conditions
- Colon Cancer
- Keywords
- Perioperative treatment, Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Mar 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.
An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Other: Enhanced recovery programearly recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery |
| Congrol group | No intervention | –Traditional, conventional perioperative treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligibility rule of enrollment
- ECOG 0-2
- Pathologically diagnosed colon cancer
- Stage I-III
- No functional disturbance in liver, kidney, bone marrow
Key exclusion criteria (8 listed)
- Emergent operation
- Obstructive or perforated cancer
- Rectosigmoid or rectal cancer
- Synchronous tumor
- Uncontrolled psychiatric or neurologic problems
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 recovery programEnhanced recovery program day-1: no mechanical bowel preparation, intake permit until 6 hrs before operation day0: operation, postoperative fluid therapy, antibiotics day1: liquid diet, early ambulation, removal of foley catheterization day2-3: soft diet day 4-5: discharge | Other | ERAS group |
Primary outcome
Length of hospital stay
Time frame: 30 days post-operatively
Duration of hospital stay from the date of operation to the date when a patient meets the following "discharge criteria". Discharge criteria: * Tolerance of consecutive 3 soft diet * Recovery of bowel function (without PONV) * No necessity of intravenous analgesics * Stable vital sign (afebrile)
Actual hospital stay
Time frame: 30 days post-operatively
5 secondary outcomes
Readmission rate
Time frame: 30 days from time of surgery
30-day morbidity
Time frame: 30 days from time of surgery
30-day mortality
Time frame: 30 days from time of surgery
Quality of life
Time frame: up to 30days from time of surgery
Nutritional status
Time frame: up to 30days from time of surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Gyu-Seog Choi, MD study chair
Kyunpook National Univercity Medical Center
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 recovery program in people with Colon Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
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: stopped early, as of the sponsor's last update on 25 Jan 2018. 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 South Korea. 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 was stopped early. Results are not available in the source record.
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: 30 days post-operatively). The study lists 2 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 Jan 2018.