Implementation of the ERAS in Colorectal Cancer Patients: a Single Arm Study

Seoul National University

Status

Invitation-only

Conditions

Colorectal Cancer

Treatments

Procedure: ERAS protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT06729736

2410-124-1579

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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