Colorectal CancerNCT07889934
Enhanced Recovery After Surgery in Patients Undergoing Colorectal Cancer Surgery
A study testing Enhanced Recovery After Surgery (ERAS) Pathway and Conventional Perioperative Care in people with Colorectal Cancer, run by University of West Attica at 1 site in Greece.
Trial summary
This study compared an Enhanced Recovery After Surgery (ERAS) care program with conventional perioperative care in adults undergoing surgery for colorectal cancer. Participants received either ERAS care or usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) Pathway and Conventional Perioperative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteGreece
- Study dates
- 17 Sep 2024to 30 Jul 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older.
- Diagnosis of colorectal cancer.
- Scheduled to undergo surgical resection of the colorectal tumor.
- Ability to understand and communicate in Greek.
- Sufficient cognitive capacity to understand the study information, provide informed consent, and participate in the study procedures.
Who cannot join
- Current treatment for chronic pain.
- Current use of antidepressant medication (moclobemide, paroxetine, sertraline, citalopram, fluoxetine, fluvoxamine, venlafaxine, mirtazapine).
- Acute or chronic renal disease.
- Acute or chronic hepatic disease.
Trial locations and contacts
1 site in 1 country.
Greece1 site
General Anticancer Oncology Hospital of Athens "Saint Savvas"
Athens, 11522
About this study
Official title: Impact of an Enhanced Recovery After Surgery (ERAS) Protocol on Postoperative Recovery in Patients Undergoing Surgery for Colorectal Cancer
This study compared an Enhanced Recovery After Surgery (ERAS) care program with conventional perioperative care in adults undergoing surgery for colorectal cancer. Participants received either ERAS care or usual care. The ERAS program included coordinated measures before, during, and after surgery aimed at supporting faster and safer recovery. The study evaluated whether ERAS was associated with a shorter length of hospital stay and improved postoperative recovery. Other outcomes included early mobilization, return of bowel function and oral feeding, postoperative pain, complications and adverse events, removal of urinary catheters and drains, discontinuation of intravenous therapy, and selected laboratory measures. The study was conducted at the General Anticancer Oncology Hospital of Athens "Saint Savvas" in Greece.
Read the detailed description
Enhanced Recovery After Surgery (ERAS) programs are multimodal, evidence-based perioperative care pathways designed to reduce the physiological stress of surgery and promote earlier functional recovery. In colorectal cancer surgery, recovery may be influenced by several factors, including postoperative pain, delayed mobilization, gastrointestinal dysfunction, prolonged intravenous therapy, and the continued use of catheters and drains.
This prospective comparative study was conducted to evaluate the implementation of an ERAS pathway in adult patients undergoing surgical resection for colorectal cancer and to compare postoperative recovery with that achieved through conventional perioperative care. A random allocation sequence was prepared before enrolment; however, its application was not recorded for each patient and allocation concealment was not used. The study is therefore reported as non-randomized. Patients operated on before the date of ethics approval were included through retrospective use of clinical data already collected, as permitted by the approving committee. The study was registered retrospectively after its completion.
The ERAS pathway incorporated coordinated interventions across the perioperative period, including preoperative preparation and education, perioperative analgesic management, postoperative mobilization, nutritional recovery, and planned discontinuation of supportive devices and therapies. Patients in the comparison group received the conventional perioperative care routinely provided at the study center.
The study focused on clinically relevant indicators of postoperative recovery. Particular attention was given to the duration of postoperative hospitalization, return of gastrointestinal function, mobilization, postoperative pain, complications and adverse events, and the timing of withdrawal of supportive interventions. Laboratory parameters were also assessed as complementary indicators of perioperative recovery.
The study was conducted in a real-world oncology hospital setting and was intended to assess whether a structured ERAS pathway was associated with improved postoperative recovery compared with the conventional perioperative care routinely provided to patients undergoing colorectal cancer surgery.
- Conditions
- Colorectal Cancer
- Being tested
- Enhanced Recovery After Surgery (ERAS) Pathway, Conventional Perioperative Care
- Keywords
- Enhanced Recovery After Surgery, ERAS, Perioperative Care, Postoperative Recovery, Length of Stay, Postoperative Complications, Postoperative Pain, Early Mobilization, Bowel Function, colorectal cancer surgery
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) PathwayOther
A multimodal perioperative care pathway applied before, during, and after colorectal cancer surgery, designed to reduce surgical stress and accelerate functional recovery.
Conventional Perioperative CareOther
Routine perioperative care provided at the study center to patients undergoing colorectal cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Experimental | Participants received a structured Enhanced Recovery After Surgery (ERAS) perioperative care pathway for colorectal cancer surgery. The pathway included coordinated perioperative measures intended to reduce surgical stress and promote earlier postoperative recovery, including preoperative preparation and education, perioperative analgesic management, postoperative mobilization, nutritional recovery, and planned discontinuation of supportive devices and therapies. Receives: Other: Enhanced Recovery After Surgery (ERAS) Pathway |
| Conventional Perioperative Care | Active comparator | Participants received the conventional perioperative care routinely provided for colorectal cancer surgery at the study center. Receives: Other: Conventional Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Length of Hospital Stay
Number of calendar days from the date of surgery to the date of hospital discharge, obtained from the hospital medical record. A shorter postoperative hospital stay indicates earlier discharge after colorectal cancer surgery.
Measured: From the date of surgery to hospital discharge, up to approximately 30 days
Secondary outcomes (9)
Time to First Postoperative Mobilization
Time from completion of surgery to the patient's first mobilization out of bed. Recovery time was recorded using predefined postoperative time categories: 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until first mobilization, assessed during the first postoperative day and thereafter if needed
Time to Full Postoperative Mobilization
Time from surgery until the patient achieved full postoperative mobilization. Time was recorded in predefined categories of 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until full mobilization
Time to Return of Gastrointestinal Motility
Time from surgery to documented return of gastrointestinal motility. Recovery time was recorded using predefined categories of 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until return of gastrointestinal motility
Time to Postoperative Oral Feeding
Time from surgery to the first postoperative oral intake of fluids or solids, recorded using predefined categories of 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until resumption of oral feeding
Postoperative Pain Intensity
Postoperative pain intensity assessed using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Pain was assessed repeatedly during the postoperative period.
Measured: 0-2, 2-6, 6-12, and 12-24 hours after surgery; postoperative days 1, 2, and 3; and at hospital discharge
Occurrence of Postoperative Complications and Adverse Events
Occurrence of one or more predefined postoperative complications or adverse events, including nausea, vomiting, constipation, drowsiness, sedation, fever, local inflammation, bleeding, urinary tract infection, urinary retention, ileus, and reoperation. Events were recorded individually and as a composite binary outcome indicating the occurrence of any complication or adverse event.
Measured: From surgery until hospital discharge
Time to Urinary Catheter Removal
Time from surgery to removal of the urinary catheter, recorded using predefined categories of 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until urinary catheter removal
Time to Surgical Drain Removal
Time from surgery to removal of postoperative surgical drains, recorded using predefined categories of 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until drain removal
Time to Discontinuation of Intravenous Therapy
Time from surgery to discontinuation of postoperative intravenous therapy, recorded using predefined categories of 0-6, 6-12, 12-18, 18-24, and more than 24 hours.
Measured: From surgery until discontinuation of intravenous therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start17 Sep 2024
- Primary completion25 Jun 2025
- Study completion30 Jul 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative study with two parallel groups. Participants received either an Enhanced Recovery After Surgery (ERAS) perioperative care pathway or conventional perioperative care. A random allocation sequence was prepared before enrolment, but adherence to the sequence was not documented at the individual patient level; the study is therefore registered as non-randomized. Outcomes were assessed during the postoperative period through hospital discharge.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Savvas Anticancer Hospital
- Responsible party
- Principal investigator, MARIA BOURAZANI, University of West Attica
- Investigators
- Martha Kelesi, Prof, Study chair, Nursing Department, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889934
- Sponsor's protocol ID
- 18111/23-12-2024
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because no prospective data-sharing framework or participant consent for external data sharing was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Enhanced Recovery After Surgery (ERAS) Protocol on Postoperative Recovery in Patients Undergoing Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07889934
- Acronym / sponsor ID
- 18111/23-12-2024
- Conditions
- Colorectal Cancer
- Keywords
- Enhanced Recovery After Surgery, ERAS, Perioperative Care, Postoperative Recovery, Length of Stay, Postoperative Complications, Postoperative Pain, Early Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Collaborators
- Saint Savvas Anticancer Hospital
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 22 Oct 2026 (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.
This study compared an Enhanced Recovery After Surgery (ERAS) care program with conventional perioperative care in adults undergoing surgery for colorectal cancer. Participants received either ERAS care or usual care. The ERAS program included coordinated measures before, during, and after surgery aimed at supporting faster and safer recovery. The study evaluated whether ERAS was associated with a shorter length of hospital stay and improved postoperative recovery. Other outcomes included early mobilization, return of bowel function and oral feeding, postoperative pain, complications and adverse events, removal of urinary catheters and drains, discontinuation of intravenous therapy, and selected laboratory measures. The study was conducted at the General Anticancer Oncology Hospital of Athens "Saint Savvas" in Greece.
Detailed description
Enhanced Recovery After Surgery (ERAS) programs are multimodal, evidence-based perioperative care pathways designed to reduce the physiological stress of surgery and promote earlier functional recovery. In colorectal cancer surgery, recovery may be influenced by several factors, including postoperative pain, delayed mobilization, gastrointestinal dysfunction, prolonged intravenous therapy, and the continued use of catheters and drains.
This prospective comparative study was conducted to evaluate the implementation of an ERAS pathway in adult patients undergoing surgical resection for colorectal cancer and to compare postoperative recovery with that achieved through conventional perioperative care. A random allocation sequence was prepared before enrolment; however, its application was not recorded for each patient and allocation concealment was not used. The study is therefore reported as non-randomized. Patients operated on before the date of ethics approval were included through retrospective use of clinical data already collected, as permitted by the approving committee. The study was registered retrospectively after its completion.
The ERAS pathway incorporated coordinated interventions across the perioperative period, including preoperative preparation and education, perioperative analgesic management, postoperative mobilization, nutritional recovery, and planned discontinuation of supportive devices and therapies. Patients in the comparison group received the conventional perioperative care routinely provided at the study center.
The study focused on clinically relevant indicators of postoperative recovery. Particular attention was given to the duration of postoperative hospitalization, return of gastrointestinal function, mobilization, postoperative pain, complications and adverse events, and the timing of withdrawal of supportive interventions. Laboratory parameters were also assessed as complementary indicators of perioperative recovery.
The study was conducted in a real-world oncology hospital setting and was intended to assess whether a structured ERAS pathway was associated with improved postoperative recovery compared with the conventional perioperative care routinely provided to patients undergoing colorectal cancer surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective comparative study with two parallel groups. Participants received either an Enhanced Recovery After Surgery (ERAS) perioperative care pathway or conventional perioperative care. A random allocation sequence was prepared before enrolment, but adherence to the sequence was not documented at the individual patient level; the study is therefore registered as non-randomized. Outcomes were assessed during the postoperative period through hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Experimental | Other: Enhanced Recovery After Surgery (ERAS) PathwayParticipants received a structured Enhanced Recovery After Surgery (ERAS) perioperative care pathway for colorectal cancer surgery. The pathway included coordinated perioperative measures intended to reduce surgical stress and promote earlier postoperative recovery, including preoperative preparation and education, perioperative analgesic management, postoperative mobilization, nutritional recovery, and planned discontinuation of supportive devices and therapies. |
| Conventional Perioperative Care | Active comparator | Other: Conventional Perioperative CareParticipants received the conventional perioperative care routinely provided for colorectal cancer surgery at the study center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Diagnosis of colorectal cancer.
- Scheduled to undergo surgical resection of the colorectal tumor.
- Ability to understand and communicate in Greek.
- Sufficient cognitive capacity to understand the study information, provide informed consent, and participate in the study procedures.
Key exclusion criteria (4 listed)
- Current treatment for chronic pain.
- Current use of antidepressant medication (moclobemide, paroxetine, sertraline, citalopram, fluoxetine, fluvoxamine, venlafaxine, mirtazapine).
- Acute or chronic renal disease.
- Acute or chronic hepatic disease.
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 |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) PathwayA multimodal perioperative care pathway applied before, during, and after colorectal cancer surgery, designed to reduce surgical stress and accelerate functional recovery. | Other | Enhanced Recovery After Surgery (ERAS) |
| Conventional Perioperative CareRoutine perioperative care provided at the study center to patients undergoing colorectal cancer surgery. | Other | Conventional Perioperative Care |
Primary outcome
Postoperative Length of Hospital Stay
Time frame: From the date of surgery to hospital discharge, up to approximately 30 days
Number of calendar days from the date of surgery to the date of hospital discharge, obtained from the hospital medical record. A shorter postoperative hospital stay indicates earlier discharge after colorectal cancer surgery.
9 secondary outcomes
Time to First Postoperative Mobilization
Time frame: From surgery until first mobilization, assessed during the first postoperative day and thereafter if needed
Time to Full Postoperative Mobilization
Time frame: From surgery until full mobilization
Time to Return of Gastrointestinal Motility
Time frame: From surgery until return of gastrointestinal motility
Time to Postoperative Oral Feeding
Time frame: From surgery until resumption of oral feeding
Postoperative Pain Intensity
Time frame: 0-2, 2-6, 6-12, and 12-24 hours after surgery; postoperative days 1, 2, and 3; and at hospital discharge
Occurrence of Postoperative Complications and Adverse Events
Time frame: From surgery until hospital discharge
Time to Urinary Catheter Removal
Time frame: From surgery until urinary catheter removal
Time to Surgical Drain Removal
Time frame: From surgery until drain removal
Time to Discontinuation of Intravenous Therapy
Time frame: From surgery until discontinuation of intravenous therapy
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 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because no prospective data-sharing framework or participant consent for external data sharing was established for this study.
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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.
Martha Kelesi, Prof study chair
Nursing Department, University of West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS) Pathway and Conventional Perioperative Care in people with Colorectal Cancer, run by University of West Attica at 1 site in Greece.
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 5 inclusion and 4 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 Nov 2026. 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 Greece. 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?
Postoperative Length of Hospital Stay (time frame: From the date of surgery to hospital discharge, up to approximately 30 days). 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 Nov 2026.