ERASSTOMIS-ERASNCT06764888
ERAS in Elderly Colorectal Cancer Surgery
An observational study of ERAS and Colo-rectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Enhanced recovery protocol consisted of a series of elements aiming to optimize and standardize perioperative care. This study aims to evaluate the safety and feasibility of a modified ERAS protocol following colorectal surgery in the elderly population, aged 65 years or older. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- ERAS, Colo-rectal Cancer, Elderly (people Aged 65 or More)
- How many people
- 1,392 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2024to 5 Dec 2024
- How long will I take part?
- 48 Months
- 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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Study population: From January 2018 to December 2022, comprehensive data on patients who underwent colorectal resection for malignancy at a single medical institute, Chang Gung Memorial Hospital, were prospectively collected and retrospectively reviewed.
Who may be able to join
- they underwent radical resection for colorectal cancer
- the procedure was minimally invasive surgery
- they were aged 65 or older
- they provided signed informed consent.
Who cannot join
- Patients who underwent emergency surgery for colorectal cancer.
- Patients with incomplete medical records or missing data relevant to the study.
- Patients with synchronous malignancies or a history of other cancers within the past five years.
- Patients with severe comorbidities (e.g., advanced cardiovascular, respiratory, or renal diseases) that contraindicate ERAS protocol implementation.
- Patients with preoperative metastatic disease or locally advanced tumors requiring palliative procedures.
- Patients who did not comply with or complete the ERAS protocol during the perioperative period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Outcomes of Minimally Invasive Surgery in Elderly Colorectal Cancer Patients in the Era of ERAS: is a "One-Size-Fits-All" Strategy Sufficient?
Enhanced recovery protocol consisted of a series of elements aiming to optimize and standardize perioperative care. This study aims to evaluate the safety and feasibility of a modified ERAS protocol following colorectal surgery in the elderly population, aged 65 years or older. This is a retrospective study based on prospectively collected data. Patient privacy has been carefully protected throughout the research process, and no aspect of this study interfered with or altered the patients' treatment or clinical care.
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| traditional care group | traditional care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term postoperative complications rate.
Measurement outcomes included the rate of short-term postoperative complications, overall morbidity, early morbidity, reoperation rate, 30-day readmission rates and 30-day mortality rates. Postoperative complications were carefully recorded and classified using the Clavien-Dindo classification system for a standardised severity evaluation. These complications are critical for assessing surgical outcomes and ensuring patient safety. Early complications were defined as those occurring during the initial hospitalisation or within 30 days of surgery, while late complications were defined as those arising after the patient's discharge from the hospital.
Measured: 3 months
Secondary outcomes (1)
Days of Hospital Stay and Time to First Passage of Flatus
Measurement outcomes are the rate of post-operative recovery times, including postoperative stay(days) and first passage of flatus(days).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start5 Jun 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,392 participants (actual)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764888
- Sponsor's protocol ID
- 202401646B0
- Acronym
- STOMIS-ERAS
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Outcomes of Minimally Invasive Surgery in Elderly Colorectal Cancer Patients in the Era of ERAS: is a "One-Size-Fits-All" Strategy Sufficient?
- ClinicalTrials.gov ID
- NCT06764888
- Acronym / sponsor ID
- STOMIS-ERAS / 202401646B0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,392 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 9 Jan 2025 (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.
Enhanced recovery protocol consisted of a series of elements aiming to optimize and standardize perioperative care. This study aims to evaluate the safety and feasibility of a modified ERAS protocol following colorectal surgery in the elderly population, aged 65 years or older. This is a retrospective study based on prospectively collected data. Patient privacy has been carefully protected throughout the research process, and no aspect of this study interfered with or altered the patients' treatment or clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traditional care group | – | –traditional care group |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- From January 2018 to December 2022, comprehensive data on patients who underwent colorectal resection for malignancy at a single medical institute, Chang Gung Memorial Hospital, were prospectively collected and retrospectively reviewed.
Key inclusion criteria (4 listed)
- they underwent radical resection for colorectal cancer
- the procedure was minimally invasive surgery
- they were aged 65 or older
- they provided signed informed consent.
Key exclusion criteria (6 listed)
- Patients who underwent emergency surgery for colorectal cancer.
- Patients with incomplete medical records or missing data relevant to the study.
- Patients with synchronous malignancies or a history of other cancers within the past five years.
- Patients with severe comorbidities (e.g., advanced cardiovascular, respiratory, or renal diseases) that contraindicate ERAS protocol implementation.
- Patients with preoperative metastatic disease or locally advanced tumors requiring palliative procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term postoperative complications rate.
Time frame: 3 months
Measurement outcomes included the rate of short-term postoperative complications, overall morbidity, early morbidity, reoperation rate, 30-day readmission rates and 30-day mortality rates. Postoperative complications were carefully recorded and classified using the Clavien-Dindo classification system for a standardised severity evaluation. These complications are critical for assessing surgical outcomes and ensuring patient safety. Early complications were defined as those occurring during the initial hospitalisation or within 30 days of surgery, while late complications were defined as those arising after the patient's discharge from the hospital.
1 secondary outcome
Days of Hospital Stay and Time to First Passage of Flatus
Time frame: 3 months
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 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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 ERAS and Colo-rectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 6 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 9 Jan 2025. 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 Taiwan. 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?
Short-term postoperative complications rate. (time frame: 3 months). 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 9 Jan 2025.