Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment

Completed

• Conditions: Colorectal Cancer; ERAS

• Registration Number: NCT06342687
• Lead Sponsor: Jagiellonian University

Brief Summary

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative 5 year survival rate	5 years

Trial Locations

Locations (1)

Jagiellonian University Medical College; 🇵🇱 Kraków, Małopolskie, Poland