Colorectal CancerNCT06342687
Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment
An observational study of Colorectal Cancer and ERAS, run by Jagiellonian University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, ERAS
- What is being tested?
- High compliance with ERAS protocol
- Type of treatment
- Surgery or procedure
- How many people
- 468 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients undergoing treatment for colorectal cancer
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, 31-008
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, ERAS
- Being tested
- High compliance with ERAS protocol
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High compliance with ERAS protocolProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | with a compliance rate with ERAS below 80% | |
| Group 2 | with a compliance rate with ERAS of 80% or above Receives: Procedure: High compliance with ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative 5 year survival rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Rubinkiewicz, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342687
- Sponsor's protocol ID
- JagiellonianU 1
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06342687
- Acronym / sponsor ID
- JagiellonianU 1
- Conditions
- Colorectal Cancer, ERAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (\<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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –with a compliance rate with ERAS below 80% |
| Group 2 | – | Procedure: High compliance with ERAS protocolwith a compliance rate with ERAS of 80% or above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients undergoing treatment for colorectal cancer
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High compliance with ERAS protocolPatients 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. | Procedure or surgery | Group 2 |
Primary outcome
Post operative 5 year survival rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and ERAS, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative 5 year survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.