Clinical trial NCT06729736: Implementation of the ERAS in Colorectal Cancer Patients: a Single Arm 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer
Keywords: ERAS
Enhanced recovery
Early recovery
Colorectal surgery
Colorectal cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
name: Samsung Medical Center
name: Asan Medical Center
name: National Cancer Center, Korea
First posted: 2024-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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'.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Postoperative time to discharge criteria
timeFrame: From the date of surgery until the date of first achieving all of the discharge criteria, assessed up to 100 days
Secondary outcomes:
measure: Adherence to the ERAS protocol
timeFrame: From date of enrollment to the date of discharge after surgery, assessed up to 100 days
measure: Hospital stay
timeFrame: From the date of hospital admission until the date of discharge after surgery, assessed up to 100 days
measure: Early postoperative complication
timeFrame: From the day of surgery to the 30th postoperative day
measure: Postoperative mortality
timeFrame: From day of surgery until the end of clinical data gathering, assessed upto 100 days.
measure: Postoperative pain score: the Numeric Rating Scale (NRS)
timeFrame: From day of surgery until the end of clinical data gathering, assessed upto 100 days.
measure: Re-admission within 30 days
timeFrame: From randomization until the end of clinical data gathering, assessed upto 100 days.
measure: Health-related Quality of Life
timeFrame: From randomization until the end of clinical data gathering, assessed upto 100 days.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Seung-Yong Jeong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: