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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Małopolskie
-
Kraków, Małopolskie, Poland, 31-008
- Jagiellonian University Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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
|
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
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JagiellonianU 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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