Clinical trial NCT06342687: Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment
Official title: Has High Compliance With Enhanced Recovery After Surgery (ERAS) Protocol Improved 5-Year Survival? - A Cohort Study of 468 Non-Metastatic Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
ERAS
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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 (\&lt;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post operative 5 year survival rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
state: Małopolskie
Study officials:
References: