Colorectal CancerNCT07324369
Effect of Preoperative ERAS Education on Recovery After Colorectal Surgery
A study testing ERAS-Based Preoperative Education and Standard Preoperative Education in people with Colorectal Cancer, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial describes the design and conduct of ERAS-based preoperative education in patients with colorectal cancer undergoing colorectal surgery. The study is conducted in the general surgery clinics of Izmir City Hospital. 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?
- ERAS-Based Preoperative Education and Standard Preoperative Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2025to 30 Oct 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
- Volunteering to participate in the study
- Age 18 years or older
- Being literate
- Ability to understand and speak Turkish
- No diagnosed psychiatric disorder
- No cognitive impairment
Show all 10Show fewer
- No visual or hearing impairment
- Being conscious, cooperative, and oriented
- Hospitalized with a diagnosis of colorectal cancer
- Scheduled to undergo colorectal surgery
Who cannot join
- Requirement for emergency surgery
- ASA score of IV or V
- Experiencing a serious complication during surgery
- Intraoperative creation of a stoma
- Admission to the intensive care unit after surgery
- Experiencing a serious postoperative complication
- Deterioration of general condition after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Education Based on ERAS Protocols on Postoperative Recovery in Patients Undergoing Colorectal Surgery: A Randomized Controlled Trial
This randomized controlled trial describes the design and conduct of ERAS-based preoperative education in patients with colorectal cancer undergoing colorectal surgery. The study is conducted in the general surgery clinics of Izmir City Hospital. Eligible patients are randomly assigned to either an intervention group receiving structured preoperative ERAS-based education supported by an educational booklet or a control group receiving standard preoperative care routinely provided in the clinic.
Postoperative recovery outcomes are predefined in the study protocol. The primary outcome is postoperative recovery on the first postoperative day, measured using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes include postoperative hospital length of stay, total length of hospital stay, reoperation during hospitalization, and 30-day readmission related to postoperative complications.
Read the detailed description
Recovery following major colorectal surgery is a multidimensional process that includes physical, physiological, psychological, and functional components. Patients undergoing colorectal surgery may experience symptoms such as pain, discomfort, reduced mobility, and anxiety during the perioperative period. Enhanced Recovery After Surgery (ERAS) protocols provide a structured, evidence-based framework for perioperative care, within which patient education is included as part of the perioperative care process.
This randomized controlled trial describes the design and implementation of ERAS-based preoperative education for patients hospitalized with colorectal cancer and scheduled for colorectal surgery, with postoperative recovery outcomes predefined in the study protocol. The study is conducted in six general surgery clinics of Izmir City Hospital between January 2025 and November 2025. Patients who meet the inclusion criteria are randomly assigned to either an intervention group receiving structured preoperative education or a control group receiving standard preoperative instructions routinely provided in the clinic.
Randomization is performed using a computer-generated randomization list, and allocation is concealed using sealed opaque envelopes. The study is conducted as a single-blind trial in which patients are not informed of their group assignment. The researcher delivering the intervention and collecting the data is aware of group allocation, while statistical analysis is performed by an independent statistician without access to group assignment information.
Intervention Description:
The intervention consists of individualized preoperative education delivered in the patient's hospital room within 48 hours prior to surgery, but not within the final 24 hours before surgery. The educational content is based on ERAS recommendations for elective colorectal surgery and includes information related to perioperative care processes, such as nausea and vomiting prevention, preoperative fasting and carbohydrate intake, antibiotic prophylaxis, skin and bowel preparation, anesthesia and fluid management, temperature management, surgical approach, postoperative pain management, early nutrition and mobilization, catheter and drain management, blood glucose control, and recognition of potential postoperative complications.
The education session lasts approximately 20 minutes and is delivered using explanation, discussion, and question-and-answer techniques. Participants in the intervention group are provided with an educational booklet developed by the researcher, written in clear and accessible language, which serves as supplementary written material for review.
Control Group:
Participants in the control group receive standard preoperative education routinely provided in the clinic as part of the usual preoperative preparation process.
Outcome Measures:
The primary outcome is postoperative recovery on the first postoperative day, assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes include postoperative hospital length of stay, total length of hospital stay, reoperation due to postoperative complications, and 30-day readmission related to postoperative complications.
Data Collection:
Participants are visited by the researcher during the preoperative period (24-48 hours before surgery) and on the first postoperative day. Data are collected through face-to-face interviews using standardized data collection instruments, and relevant clinical information is obtained from medical records. Information regarding 30-day readmission is retrieved from electronic hospital databases following discharge.
- Conditions
- Colorectal Cancer
- Being tested
- ERAS-Based Preoperative Education, Standard Preoperative Education
- Keywords
- enhanced recovery after surgery, colorectal cancers, colorectal surgery, patient education, preoperative care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-Based Preoperative EducationBehavioural
A structured, individualized preoperative education session based on ERAS recommendations for colorectal surgery. The education includes information on preoperative, intraoperative, and postoperative practices. It is delivered by the researcher in a single 20-minute session within 48 hours before surgery (excluding the last 24 hours) and supported with a written educational booklet.
Standard Preoperative EducationBehavioural
Routine preoperative education provided by the ward nurse as part of the hospital's standard surgical preparation process. This education reflects usual care and does not include ERAS-based content or additional materials.
| Study group | Role | What they receive |
|---|---|---|
| ERAS-Based Preoperative Education | Experimental | A structured preoperative education intervention based on ERAS recommendations for colorectal surgery. The session includes key components of preoperative, intraoperative, and postoperative care and is delivered once within 48 hours before surgery. A written educational booklet is provided to support patient understanding. Receives: Behavioral: ERAS-Based Preoperative Education |
| Standard Preoperative Education | Active comparator | Routine preoperative education delivered by the ward nurse as part of the hospital's standard surgical preparation practices. No ERAS-based materials or additional educational content are included. Receives: Behavioral: Standard Preoperative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-40 (QoR-40) score on postoperative day 1
The QoR-40 questionnaire assesses postoperative recovery across five domains: emotional state, physical comfort, psychological support, physical independence, and pain. Higher scores indicate better quality of recovery. Total scores range from 40 to 200, with higher scores indicating better quality of recovery.
Measured: Postoperative day 1 (24 hours after surgery)
Secondary outcomes (4)
Postoperative hospital length of stay
Number of days the patient remains hospitalized after surgery.
Measured: From the end of surgery through hospital discharge (up to 30 days)
Total hospital length of stay
Total number of days hospitalized, including preoperative and postoperative days.
Measured: From the day of hospital admission through hospital discharge (up to 30 days)
Reoperation due to postoperative complications
Occurrence of unplanned return to the operating room due to complications following the index surgery.
Measured: From the end of surgery through hospital discharge (up to 30 days)
30-day hospital readmission due to complication
Readmission to the hospital caused by postoperative complications, as documented in electronic medical records.
Measured: Within 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start21 Jan 2025
- Primary completion30 Sep 2025
- Study completion30 Oct 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a two-arm, parallel assignment randomized controlled design. Participants were individually randomized in a 1:1 ratio to either the intervention group, which received ERAS-based preoperative education, or the control group, which received standard preoperative care. Randomization was performed using a computer-generated sequence, and allocation was concealed with sealed opaque envelopes. The study was conducted as a single-blind trial in which the outcomes assessor (statistician) was blinded to group assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir City Hospital
- Responsible party
- Principal investigator, Deniz Şanlı, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324369
- Sponsor's protocol ID
- 0099
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study is a master's thesis project, and the informed consent form does not include permission for public data sharing. In addition, the dataset contains sensitive clinical information, and institutional policies do not allow disclosure of identifiable or de-identified patient data for external research use.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Education Based on ERAS Protocols on Postoperative Recovery in Patients Undergoing Colorectal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07324369
- Acronym / sponsor ID
- 0099
- Conditions
- Colorectal Cancer
- Keywords
- enhanced recovery after surgery, colorectal cancers, colorectal surgery, patient education, preoperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Izmir City Hospital
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 7 Jan 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 randomized controlled trial describes the design and conduct of ERAS-based preoperative education in patients with colorectal cancer undergoing colorectal surgery. The study is conducted in the general surgery clinics of Izmir City Hospital. Eligible patients are randomly assigned to either an intervention group receiving structured preoperative ERAS-based education supported by an educational booklet or a control group receiving standard preoperative care routinely provided in the clinic.
Postoperative recovery outcomes are predefined in the study protocol. The primary outcome is postoperative recovery on the first postoperative day, measured using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes include postoperative hospital length of stay, total length of hospital stay, reoperation during hospitalization, and 30-day readmission related to postoperative complications.
Detailed description
Recovery following major colorectal surgery is a multidimensional process that includes physical, physiological, psychological, and functional components. Patients undergoing colorectal surgery may experience symptoms such as pain, discomfort, reduced mobility, and anxiety during the perioperative period. Enhanced Recovery After Surgery (ERAS) protocols provide a structured, evidence-based framework for perioperative care, within which patient education is included as part of the perioperative care process.
This randomized controlled trial describes the design and implementation of ERAS-based preoperative education for patients hospitalized with colorectal cancer and scheduled for colorectal surgery, with postoperative recovery outcomes predefined in the study protocol. The study is conducted in six general surgery clinics of Izmir City Hospital between January 2025 and November 2025. Patients who meet the inclusion criteria are randomly assigned to either an intervention group receiving structured preoperative education or a control group receiving standard preoperative instructions routinely provided in the clinic.
Randomization is performed using a computer-generated randomization list, and allocation is concealed using sealed opaque envelopes. The study is conducted as a single-blind trial in which patients are not informed of their group assignment. The researcher delivering the intervention and collecting the data is aware of group allocation, while statistical analysis is performed by an independent statistician without access to group assignment information.
Intervention Description:
The intervention consists of individualized preoperative education delivered in the patient's hospital room within 48 hours prior to surgery, but not within the final 24 hours before surgery. The educational content is based on ERAS recommendations for elective colorectal surgery and includes information related to perioperative care processes, such as nausea and vomiting prevention, preoperative fasting and carbohydrate intake, antibiotic prophylaxis, skin and bowel preparation, anesthesia and fluid management, temperature management, surgical approach, postoperative pain management, early nutrition and mobilization, catheter and drain management, blood glucose control, and recognition of potential postoperative complications.
The education session lasts approximately 20 minutes and is delivered using explanation, discussion, and question-and-answer techniques. Participants in the intervention group are provided with an educational booklet developed by the researcher, written in clear and accessible language, which serves as supplementary written material for review.
Control Group:
Participants in the control group receive standard preoperative education routinely provided in the clinic as part of the usual preoperative preparation process.
Outcome Measures:
The primary outcome is postoperative recovery on the first postoperative day, assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes include postoperative hospital length of stay, total length of hospital stay, reoperation due to postoperative complications, and 30-day readmission related to postoperative complications.
Data Collection:
Participants are visited by the researcher during the preoperative period (24-48 hours before surgery) and on the first postoperative day. Data are collected through face-to-face interviews using standardized data collection instruments, and relevant clinical information is obtained from medical records. Information regarding 30-day readmission is retrieved from electronic hospital databases following discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a two-arm, parallel assignment randomized controlled design. Participants were individually randomized in a 1:1 ratio to either the intervention group, which received ERAS-based preoperative education, or the control group, which received standard preoperative care. Randomization was performed using a computer-generated sequence, and allocation was concealed with sealed opaque envelopes. The study was conducted as a single-blind trial in which the outcomes assessor (statistician) was blinded to group assignment.
| Arm | Type | Receives |
|---|---|---|
| ERAS-Based Preoperative Education | Experimental | Behavioral: ERAS-Based Preoperative EducationA structured preoperative education intervention based on ERAS recommendations for colorectal surgery. The session includes key components of preoperative, intraoperative, and postoperative care and is delivered once within 48 hours before surgery. A written educational booklet is provided to support patient understanding. |
| Standard Preoperative Education | Active comparator | Behavioral: Standard Preoperative EducationRoutine preoperative education delivered by the ward nurse as part of the hospital's standard surgical preparation practices. No ERAS-based materials or additional educational content are included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteering to participate in the study
- Age 18 years or older
- Being literate
- Ability to understand and speak Turkish
- No diagnosed psychiatric disorder
Key exclusion criteria (7 listed)
- Requirement for emergency surgery
- ASA score of IV or V
- Experiencing a serious complication during surgery
- Intraoperative creation of a stoma
- Admission to the intensive care unit after surgery
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 |
|---|---|---|
| ERAS-Based Preoperative EducationA structured, individualized preoperative education session based on ERAS recommendations for colorectal surgery. The education includes information on preoperative, intraoperative, and postoperative practices. It is delivered by the researcher in a single 20-minute session within 48 hours before surgery (excluding the last 24 hours) and supported with a written educational booklet. | Behavioural | ERAS-Based Preoperative Education |
| Standard Preoperative EducationRoutine preoperative education provided by the ward nurse as part of the hospital's standard surgical preparation process. This education reflects usual care and does not include ERAS-based content or additional materials. | Behavioural | Standard Preoperative Education |
Primary outcome
Quality of Recovery-40 (QoR-40) score on postoperative day 1
Time frame: Postoperative day 1 (24 hours after surgery)
The QoR-40 questionnaire assesses postoperative recovery across five domains: emotional state, physical comfort, psychological support, physical independence, and pain. Higher scores indicate better quality of recovery. Total scores range from 40 to 200, with higher scores indicating better quality of recovery.
4 secondary outcomes
Postoperative hospital length of stay
Time frame: From the end of surgery through hospital discharge (up to 30 days)
Total hospital length of stay
Time frame: From the day of hospital admission through hospital discharge (up to 30 days)
Reoperation due to postoperative complications
Time frame: From the end of surgery through hospital discharge (up to 30 days)
30-day hospital readmission due to complication
Time frame: Within 30 days after discharge
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 7 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is a master's thesis project, and the informed consent form does not include permission for public data sharing. In addition, the dataset contains sensitive clinical information, and institutional policies do not allow disclosure of identifiable or de-identified patient data for external research use.
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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?
A study testing ERAS-Based Preoperative Education and Standard Preoperative Education in people with Colorectal Cancer, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 10 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 7 Jan 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 Turkey (Türkiye). 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?
Quality of Recovery-40 (QoR-40) score on postoperative day 1 (time frame: Postoperative day 1 (24 hours after surgery)). 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 7 Jan 2026.