Implementation of the ERAS in Colorectal Cancer Patients: a Single Arm Study
NCT ID: NCT06729736
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
500 participants
INTERVENTIONAL
2024-12-01
2026-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ERAS implemented arm
ERAS protocol implemented patients (single arm).
ERAS protocol
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
Interventions
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ERAS protocol
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Emergency surgery
* Scheduled for transanal surgery
* Perforated colorectal cancer
* Obstructed colorectal cancer
* Familial colorectal cancer (HNPCC, FAP, MUYH polyposis, Peutz-Jeghers syndrome)
* 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
19 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Boramae Hospital
OTHER
Samsung Medical Center
OTHER
Asan Medical Center
OTHER
National Cancer Center, Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Seung-Yong Jeong, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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2410-124-1579
Identifier Type: -
Identifier Source: org_study_id