Colorectal CancerNCT06729736
Implementation of the ERAS in Colorectal Cancer Patients: a Single Arm Study
A study testing ERAS protocol in people with Colorectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this study is to implement and investigate the efficacy of an Early Recovery After Surgery (ERAS) protocol in South Korean colorectal cancer patients. The primary outcome will be the postoperative time taken to achieve the 'discharge criteria'. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above the age of 19 years
- Pathologic diagnosis of colon cancer or rectal cancer
- Scheduled for minimally invasive (laparoscopic or robotic) colorectal cancer surgery
- Agreed to participate after a detailed explanation of the study
Who cannot join
- Stage 4 (distant metastasis)
- Emergency surgery
- Scheduled for transanal surgery
- Perforated colorectal cancer
- Obstructed colorectal cancer
- Familial colorectal cancer (HNPCC, FAP, MUYH polyposis, Peutz-Jeghers syndrome)
Show all 11Show fewer
- Previous treatment for colorectal cancer
- History of other cancer within 5 years (excluding skin cancer)
- Acute infection
- Unable to read or understand the study
- Mental impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of the Early Recovery After Surgery (ERAS) Protocol in Colorectal Cancer Patients: a Phase II Multi-Center, Prospective Single Arm Study
The goal of this study is to implement and investigate the efficacy of an Early Recovery After Surgery (ERAS) protocol in South Korean colorectal cancer patients.
The primary outcome will be the postoperative time taken to achieve the 'discharge criteria'.
Secondary outcomes will include adherence, hospital stay, early complications, mortality, pain scores, re-admission and quality of life questionnaire scores.
As a single arm study, all participants will be treated according to an ERAS protocol, which includes components such as early ambulation, minimal fasting, multimodal pain control and omission of- or early removal of invasive catheters.
Read the detailed description
This multi-center prospective single arm clinical trial aims to investigate each component and item in the ERAS protocol implemented to perioperative care of colorectal cancer patients.
The primary endpoint will be the 'postoperative time to discharge criteria'. Discharge criteria will be defined as meeting all the criteria below:
- No fever
- Eating more than half of given solid diet
- No nausea or vomiting
- Gas passing or defecation
- Able to walk (more than 1 hour a day)
- No sign of surgical site infection
- Adequate pain control with oral analgesics such as acetaminophen and NSAIDs
- No sign of any other complication
Secondary outcomes will include:
- adherence of each ERAS item within the protocol
- postoperative hospital stay
- early postoperative complications (within 30 days of surgery)
- postoperative mortality
- postoperative pain scores (VAS scores)
- re-admission within 30 days of surgery
- Quality of Recovery questionnaire
- Health-related quality of life questionnaire
The specific ERAS protocol to be used in this study has been developed by Seoul National University Hospital, benchmarking the 2018 ERAS® society guidelines for colorectal surgery. The implementation process has been helped and guided by the ERAS® Implementation Program of the Encare team.
The ERAS protocol includes:
- Pre-admission education, counselling and nutritional support
- Pre-induction oral analgesics
- Minimal fasting and carbohydrate loading
- Omission of nasogastric intubation
- Intra-operative abdominal nerve block
- Early mobilization
- Early oral nutrition and minimal IV fluids
- Multimodal opioid sparing analgesia
- Postoperative nausea and vomiting prophylaxis
- Early removal of urinary catheters
This study aims to establish evidence on the factors affecting adherence and efficacy of each ERAS category, to guide a future pivotal RCT that will aim to develop a personalized, risk-stratified ERAS protocol that considers surgical risk and patient factors.
- Conditions
- Colorectal Cancer
- Being tested
- ERAS protocol
- Keywords
- ERAS, Enhanced recovery, Early recovery, Colorectal 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.
ERAS protocolProcedure or surgery
The ERAS protocol includes:
- Pre-admission education, counselling and nutritional support
- Pre-induction oral analgesics
- Minimal fasting and carbohydrate loading
- Omission of nasogastric intubation
- Intra-operative abdominal nerve block
- Early mobilization
- Early oral nutrition and minimal IV fluids
- Multimodal opioid sparing analgesia
- Postoperative nausea and vomiting prophylaxis
- Early removal of urinary catheters
| Study group | Role | What they receive |
|---|---|---|
| ERAS implemented arm | Experimental | ERAS protocol implemented patients (single arm). Receives: Procedure: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative time to discharge criteria
The time (days) from initiation of surgery to achieving the discharge criteria. Discharge criteria is defined as meeting all of the following criteria:
- No fever
- Eating more than half of given solid diet
- No nausea or vomiting
- Gas passing or defecation
- Able to walk (more than 1 hour a day)
- No sign of surgical site infection
- Adequate pain control with oral analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs)
- No sign of any other complication
Measured: From the date of surgery until the date of first achieving all of the discharge criteria, assessed up to 100 days
Secondary outcomes (7)
Adherence to the ERAS protocol
Adherence to each item in the ERAS protocol
Measured: From date of enrollment to the date of discharge after surgery, assessed up to 100 days
Hospital stay
Total length of hospital stay for surgery.
Measured: From the date of hospital admission until the date of discharge after surgery, assessed up to 100 days
Early postoperative complication
Postoperative complication within 30 days of surgery.
Measured: From the day of surgery to the 30th postoperative day
Postoperative mortality
Death caused by the surgery itself or any complication related to surgery.
Measured: From day of surgery until the end of clinical data gathering, assessed upto 100 days.
Postoperative pain score: the Numeric Rating Scale (NRS)
Postoperative pain, evaluated using the Numeric Rating Scale (NRS) scale. This scale ranges from 0 to 10, with increasing values representing more severe pain.
0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Pain scores at rest, and pain scores at movement will be collected and analyzed separately.
Measured: From day of surgery until the end of clinical data gathering, assessed upto 100 days.
Re-admission within 30 days
Re-admission due to surgery complication within 30 days of surgery.
Measured: From randomization until the end of clinical data gathering, assessed upto 100 days.
Health-related Quality of Life
Health related quality of life, assessed using the 5-level EQ-5D version (EQ-5D-5L) questionnaire.
The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: From randomization until the end of clinical data gathering, assessed upto 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Seoul National University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Samsung Medical Center, Asan Medical Center, National Cancer Center, Korea
- Responsible party
- Sponsor
- Investigators
- Seung-Yong Jeong, M.D., Ph.D., Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729736
- Sponsor's protocol ID
- 2410-124-1579
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Early Recovery After Surgery (ERAS) Protocol in Colorectal Cancer Patients: a Phase II Multi-Center, Prospective Single Arm Study
- ClinicalTrials.gov ID
- NCT06729736
- Acronym / sponsor ID
- 2410-124-1579
- Conditions
- Colorectal Cancer
- Keywords
- ERAS, Enhanced recovery, Early recovery, Colorectal surgery, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Samsung Medical Center, Asan Medical Center, National Cancer Center, Korea
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- 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.
The goal of this study is to implement and investigate the efficacy of an Early Recovery After Surgery (ERAS) protocol in South Korean colorectal cancer patients.
The primary outcome will be the postoperative time taken to achieve the 'discharge criteria'.
Secondary outcomes will include adherence, hospital stay, early complications, mortality, pain scores, re-admission and quality of life questionnaire scores.
As a single arm study, all participants will be treated according to an ERAS protocol, which includes components such as early ambulation, minimal fasting, multimodal pain control and omission of- or early removal of invasive catheters.
Detailed description
This multi-center prospective single arm clinical trial aims to investigate each component and item in the ERAS protocol implemented to perioperative care of colorectal cancer patients.
The primary endpoint will be the 'postoperative time to discharge criteria'. Discharge criteria will be defined as meeting all the criteria below:
- No fever
- Eating more than half of given solid diet
- No nausea or vomiting
- Gas passing or defecation
- Able to walk (more than 1 hour a day)
- No sign of surgical site infection
- Adequate pain control with oral analgesics such as acetaminophen and NSAIDs
- No sign of any other complication
Secondary outcomes will include:
- adherence of each ERAS item within the protocol
- postoperative hospital stay
- early postoperative complications (within 30 days of surgery)
- postoperative mortality
- postoperative pain scores (VAS scores)
- re-admission within 30 days of surgery
- Quality of Recovery questionnaire
- Health-related quality of life questionnaire
The specific ERAS protocol to be used in this study has been developed by Seoul National University Hospital, benchmarking the 2018 ERAS® society guidelines for colorectal surgery. The implementation process has been helped and guided by the ERAS® Implementation Program of the Encare team.
The ERAS protocol includes:
- Pre-admission education, counselling and nutritional support
- Pre-induction oral analgesics
- Minimal fasting and carbohydrate loading
- Omission of nasogastric intubation
- Intra-operative abdominal nerve block
- Early mobilization
- Early oral nutrition and minimal IV fluids
- Multimodal opioid sparing analgesia
- Postoperative nausea and vomiting prophylaxis
- Early removal of urinary catheters
This study aims to establish evidence on the factors affecting adherence and efficacy of each ERAS category, to guide a future pivotal RCT that will aim to develop a personalized, risk-stratified ERAS protocol that considers surgical risk and patient factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERAS implemented arm | Experimental | Procedure: ERAS protocolERAS protocol implemented patients (single arm). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above the age of 19 years
- Pathologic diagnosis of colon cancer or rectal cancer
- Scheduled for minimally invasive (laparoscopic or robotic) colorectal cancer surgery
- Agreed to participate after a detailed explanation of the study
Key exclusion criteria (11 listed)
- Stage 4 (distant metastasis)
- Emergency surgery
- Scheduled for transanal surgery
- Perforated colorectal cancer
- Obstructed colorectal cancer
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 |
|---|---|---|
| ERAS protocolThe ERAS protocol includes: * Pre-admission education, counselling and nutritional support * Pre-induction oral analgesics * Minimal fasting and carbohydrate loading * Omission of nasogastric intubation * Intra-operative abdominal nerve block * Early mobilization * Early oral nutrition and minimal IV fluids * Multimodal opioid sparing analgesia * Postoperative nausea and vomiting prophylaxis * Early removal of urinary catheters | Procedure or surgery | ERAS implemented arm |
Primary outcome
Postoperative time to discharge criteria
Time frame: From the date of surgery until the date of first achieving all of the discharge criteria, assessed up to 100 days
The time (days) from initiation of surgery to achieving the discharge criteria. Discharge criteria is defined as meeting all of the following criteria: * No fever * Eating more than half of given solid diet * No nausea or vomiting * Gas passing or defecation * Able to walk (more than 1 hour a day) * No sign of surgical site infection * Adequate pain control with oral analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) * No sign of any other complication
7 secondary outcomes
Adherence to the ERAS protocol
Time frame: From date of enrollment to the date of discharge after surgery, assessed up to 100 days
Hospital stay
Time frame: From the date of hospital admission until the date of discharge after surgery, assessed up to 100 days
Early postoperative complication
Time frame: From the day of surgery to the 30th postoperative day
Postoperative mortality
Time frame: From day of surgery until the end of clinical data gathering, assessed upto 100 days.
Postoperative pain score: the Numeric Rating Scale (NRS)
Time frame: From day of surgery until the end of clinical data gathering, assessed upto 100 days.
Re-admission within 30 days
Time frame: From randomization until the end of clinical data gathering, assessed upto 100 days.
Health-related Quality of Life
Time frame: From randomization until the end of clinical data gathering, assessed upto 100 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Seung-Yong Jeong, M.D., Ph.D. principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol in people with Colorectal Cancer, run by Seoul 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 4 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 11 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative time to discharge criteria (time frame: From the date of surgery until the date of first achieving all of the discharge criteria, assessed up to 100 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 11 Dec 2024.