Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment
NCT ID: NCT06342687
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
468 participants
OBSERVATIONAL
2018-01-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group 1
with a compliance rate with ERAS below 80%
No interventions assigned to this group
Group 2
with a compliance rate with ERAS of 80% or above
High compliance with ERAS protocol
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.
Interventions
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High compliance with ERAS protocol
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Mateusz Rubinkiewicz
MD PhD
Locations
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Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, Poland
Countries
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Other Identifiers
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JagiellonianU 1
Identifier Type: -
Identifier Source: org_study_id
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