Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment

Jagiellonian University

Status: Completed

Conditions: ERAS; Colorectal Cancer

Treatments: Procedure: High compliance with ERAS protocol

Study type: Observational

Funder types: Other

Identifiers

NCT06342687

JagiellonianU 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

468 participants in 2 patient groups

Group 1

Description:

with a compliance rate with ERAS below 80%

Group 2

Description:

with a compliance rate with ERAS of 80% or above

Treatment:

Procedure: High compliance with ERAS protocol