Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342687
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lt80
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
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 lt80
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None