Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment

Has High Compliance With Enhanced Recovery After Surgery (ERAS) Protocol Improved 5-Year Survival? - A Cohort Study of 468 Non-Metastatic Colorectal Cancer Patients

The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; ERAS
• Intervention / Treatment: Procedure: High compliance with ERAS protocol

Detailed Description

The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.

The study will be designed as a prospective observational study to compare the long-term effects of surgical treatment of colorectal cancer in two groups of patients: those with high compliance with the ERAS protocol (≥80%) and those with low compliance with the ERAS protocol (<80%).

The primary outcome of the study will be the 5-year survival rate. The inclusion criteria for Group 1 will involve 128 patients with ERAS compliance below 80%. Conversely, Group 2 will consist of 340 patients, all of whom achieved a compliance rate of at least 80%.

The correlation between compliance with the ERAS protocol and 5-year survival will be assessed using the Kaplan-Meier method with log-rank tests. Additionally, survival analysis will be conducted separately for groups with varying cancer stages.

• Study Type: Observational
• Enrollment (Actual): 468

Contacts and Locations

Study Locations

• Poland
  • Małopolskie
    • Kraków, Małopolskie, Poland, 31-008
      • Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients will be divided into two groups based on ERAS protocol compliance. Group 1 comprised patients with adherence below 80%, while Group 2 consisted of individuals who maintained adherence levels of no less than 80%. We established this threshold based on the compliance target set in our clinic.

Description

Inclusion Criteria:

• patients undergoing treatment for colorectal cancer

Exclusion Criteria:

• primary open or emergency surgery,
• transanal endoscopic microsurgery (TEM),
• stage IV of the disease according to the American Joint Committee on Cancer (AJCC) classification,
• multivisceral resection,
• concomitant inflammatory bowel diseases,
• intensive care unit stay immediately after surgery
• lost-to-follow-up patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; with a compliance rate with ERAS below 80%
Group 2; with a compliance rate with ERAS of 80% or above	Procedure: High compliance with ERAS protocol; Patients were categorized into two groups based on their adherence to the ERAS protocol: group 1 with a compliance rate below 80% and group 2 with a compliance rate of 80% or above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post operative 5 year survival rate	5 years

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: JagiellonianU 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No