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

NCT06729736 | Enrolling By Invitation DMC

• 1 other identifier: 2410-124-1579
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

ERAS; Enhanced recovery; Early recovery; Colorectal surgery; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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

  From date of enrollment to the date of discharge after surgery, assessed up to 100 days

• Hospital stay

  From the date of hospital admission until the date of discharge after surgery, assessed up to 100 days

• Early postoperative complication

  From the day of surgery to the 30th postoperative day

• Postoperative mortality

  From day of surgery until the end of clinical data gathering, assessed upto 100 days.

• Postoperative pain score: the Numeric Rating Scale (NRS)

  From day of surgery until the end of clinical data gathering, assessed upto 100 days.

Study Arms (1)

ERAS implemented arm

EXPERIMENTAL

ERAS protocol implemented patients (single arm).

Procedure: ERAS protocol

Interventions

ERAS protocol PROCEDURE

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

ERAS implemented arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• National Cancer Center, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Seung-Yong Jeong, M.D., Ph.D.

  Seoul National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)