Colo-rectal CancerNCT06660303
Preoperative Patient Education for Enhanced Recovery After Colon and Rectal Surgery
A study testing Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery and Routine hospital care in people with Colo-rectal Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this experimental study is to evaluate whether **preoperative patient education can improve outcomes for individuals undergoing colorectal surgery. This study will focus on adult male and female patients with colon cancer scheduled for colorectal surgery through colonoscopy, excluding those undergoing open… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery and Routine hospital care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2024to 22 Oct 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients with colon cancer undergoing colorectal surgery via colonoscope.
Who cannot join
- patients with open surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this experimental study is to evaluate whether **preoperative patient education can improve outcomes for individuals undergoing colorectal surgery. This study will focus on adult male and female patients with colon cancer scheduled for colorectal surgery through colonoscopy, excluding those undergoing open surgery.
The primary questions this study seeks to answer are:
Read more
- Do patients who receive preoperative education experience significantly lower levels of preoperative anxiety compared to those receiving routine hospital care?
- Do patients receiving nursing instructions report significantly lower levels of oral pain postoperatively compared to those who do not?
- Does preoperative education lead to higher levels of patient satisfaction compared to standard care?
Researchers will compare a study group that receives preoperative education to a control group receiving routine hospital care to determine the effectiveness of the intervention.
Participants will be asked to:
- Complete a demographic and medical history questionnaire.
- Utilize the Pain Numeric Rating Scale (NRS-11) to self-report pain levels.
- Participate in assessments using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)**.
- Complete a satisfaction survey using the Colorectal Surgical Patient's Satisfaction Tool after surgery.
The study aims to assess the impact of preoperative education on anxiety, pain management, and overall patient satisfaction.
Read the detailed description
Patient education and engagement are fundamental components of modern integrated colorectal care pathways. Surgeons and nurses play a crucial role in providing comprehensive education about what patients can expect during both the preoperative and postoperative phases of surgery. Setting clear expectations early-especially regarding the anticipated discharge date-significantly influences the postoperative recovery journey.
Enhanced Recovery After Surgery (ERAS) is an evidence-based, patient-focused strategy aimed at optimizing surgical outcomes by streamlining the recovery process. Initially designed for colorectal procedures, ERAS protocols have now been adapted for various surgical disciplines, with many of its principles safely applicable to most perioperative patients. The primary objective of ERAS is to minimize the physical and emotional strain of surgery, facilitating quicker recovery, reducing complications, and decreasing the length of hospital stays.
While much of the research on the ERAS program has traditionally centered on the surgeon's role, the multidisciplinary nature of patient care has brought increased recognition to the nurse's contribution. Nursing professionals are now acknowledged as vital components of the ERAS framework, playing a key role in ensuring the program's success.
- Conditions
- Colo-rectal Cancer
- Being tested
- Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery, Routine hospital care
- Keywords
- Preoperative Education, Nursing Intervention, Enhanced Recovery After Surgery (ERAS)
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Preoperative Education for Enhanced Recovery in Colorectal SurgeryBehavioural
The intervention in this study involves preoperative patient education aimed at improving outcomes for individuals undergoing colorectal surgery. Patients in the study group will receive targeted educational sessions that focus on setting expectations, managing anxiety, understanding pain control, and preparing for the surgical process as part of the Enhanced Recovery After Surgery (ERAS) protocol. This educational approach is designed to empower patients, reduce anxiety, enhance satisfaction, and potentially improve post-surgical recovery compared to those receiving routine hospital care.
Routine hospital careOther
The control group, designated as Group II, will receive standard hospital care, encompassing the usual preoperative and postoperative procedures provided by the hospital. This includes typical preparation and recovery guidelines without any added specialized preoperative education or targeted nursing instructions. This routine hospital care serves as a baseline, allowing for a direct comparison of outcomes against the intervention group, which will receive comprehensive preoperative education aimed at enhancing recovery and improving surgical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients who will receive comprehensive preoperative education tailored to their upcoming colorectal surgery. This education covers what to expect during the surgical process, postoperative care, pain management strategies, and guidelines to aid faster recovery. |
| Control Group | Active comparator | Participants which will receive routine hospital care. This means that participants in this group will go through the standard preoperative and postoperative procedures typically provided at the hospital without any additional specialized preoperative education or targeted nursing instructions Receives: Other: Routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating Scale
pain Numeric Rating Scale (NRS-11) is 10-point scale for patient self-reporting of pain. It is for adults as 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
Measured: 1 week
Secondary outcomes (1)
Amsterdam preoperative anxiety and information scale (APAIS)
is scale consists of four items (questions 1, 2, 4, 5), each of which could be scored from 1 to 5. The score of the anxiety scale is the sum of these four questions, with a scoring range from 4 to 20.it is developed by Moerman, van Dam, Muller \& Oosting. (1996). Reliability was 0.74.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start30 Jul 2024
- Primary completion1 Sep 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elsayed Zaky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660303
- Sponsor's protocol ID
- Preoperative Patient Education
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
PubMed 30426190Dipokromo, A., Sherman, D. W., & Lago Sr, C. (2022). Preoperative Education Regarding the Enhanced Recovery After Surgery (ERAS) Guideline for colorectal Surgical Patients: A Quality Improvement Project.
Carrilho, M. P. G., Pontífice-Sousa, P., & Marques, R. M. D. (2021). ERAS® Program-Nursing care for patients undergoing colorectal surgery. Acta Paulista de Enfermagem, 34, eAPE002105.
Abd El-Aziz E. The Effect of the Application of Clinical Pathway on Postoperative Outcomes of Patients Undergoing Percutaneous Nephrolithotomy. Alexandria University, Faculty of Nursing: Unpublished DSN dissertation. 2011.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Patient Education for Enhanced Recovery After Colon and Rectal Surgery
- ClinicalTrials.gov ID
- NCT06660303
- Acronym / sponsor ID
- Preoperative Patient Education
- Conditions
- Colo-rectal Cancer
- Keywords
- Preoperative Education, Nursing Intervention, Enhanced Recovery After Surgery (ERAS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 28 Oct 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 aim of this experimental study is to evaluate whether **preoperative patient education can improve outcomes for individuals undergoing colorectal surgery. This study will focus on adult male and female patients with colon cancer scheduled for colorectal surgery through colonoscopy, excluding those undergoing open surgery.
The primary questions this study seeks to answer are:
- Do patients who receive preoperative education experience significantly lower levels of preoperative anxiety compared to those receiving routine hospital care?
- Do patients receiving nursing instructions report significantly lower levels of oral pain postoperatively compared to those who do not?
- Does preoperative education lead to higher levels of patient satisfaction compared to standard care?
Researchers will compare a study group that receives preoperative education to a control group receiving routine hospital care to determine the effectiveness of the intervention.
Participants will be asked to:
- Complete a demographic and medical history questionnaire.
- Utilize the Pain Numeric Rating Scale (NRS-11) to self-report pain levels.
- Participate in assessments using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)**.
- Complete a satisfaction survey using the Colorectal Surgical Patient's Satisfaction Tool after surgery.
The study aims to assess the impact of preoperative education on anxiety, pain management, and overall patient satisfaction.
Detailed description
Patient education and engagement are fundamental components of modern integrated colorectal care pathways. Surgeons and nurses play a crucial role in providing comprehensive education about what patients can expect during both the preoperative and postoperative phases of surgery. Setting clear expectations early-especially regarding the anticipated discharge date-significantly influences the postoperative recovery journey.
Enhanced Recovery After Surgery (ERAS) is an evidence-based, patient-focused strategy aimed at optimizing surgical outcomes by streamlining the recovery process. Initially designed for colorectal procedures, ERAS protocols have now been adapted for various surgical disciplines, with many of its principles safely applicable to most perioperative patients. The primary objective of ERAS is to minimize the physical and emotional strain of surgery, facilitating quicker recovery, reducing complications, and decreasing the length of hospital stays.
While much of the research on the ERAS program has traditionally centered on the surgeon's role, the multidisciplinary nature of patient care has brought increased recognition to the nurse's contribution. Nursing professionals are now acknowledged as vital components of the ERAS framework, playing a key role in ensuring the program's success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | –Patients who will receive comprehensive preoperative education tailored to their upcoming colorectal surgery. This education covers what to expect during the surgical process, postoperative care, pain management strategies, and guidelines to aid faster recovery. |
| Control Group | Active comparator | Other: Routine hospital careParticipants which will receive routine hospital care. This means that participants in this group will go through the standard preoperative and postoperative procedures typically provided at the hospital without any additional specialized preoperative education or targeted nursing instructions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male and female patients with colon cancer undergoing colorectal surgery via colonoscope.
Key exclusion criteria (1 listed)
- patients with open 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 |
|---|---|---|
| Comprehensive Preoperative Education for Enhanced Recovery in Colorectal SurgeryThe intervention in this study involves preoperative patient education aimed at improving outcomes for individuals undergoing colorectal surgery. Patients in the study group will receive targeted educational sessions that focus on setting expectations, managing anxiety, understanding pain control, and preparing for the surgical process as part of the Enhanced Recovery After Surgery (ERAS) protocol. This educational approach is designed to empower patients, reduce anxiety, enhance satisfaction, and potentially improve post-surgical recovery compared to those receiving routine hospital care. | Behavioural | – |
| Routine hospital careThe control group, designated as Group II, will receive standard hospital care, encompassing the usual preoperative and postoperative procedures provided by the hospital. This includes typical preparation and recovery guidelines without any added specialized preoperative education or targeted nursing instructions. This routine hospital care serves as a baseline, allowing for a direct comparison of outcomes against the intervention group, which will receive comprehensive preoperative education aimed at enhancing recovery and improving surgical outcomes. | Other | Control Group |
Primary outcome
Pain Rating Scale
Time frame: 1 week
pain Numeric Rating Scale (NRS-11) is 10-point scale for patient self-reporting of pain. It is for adults as 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
1 secondary outcome
Amsterdam preoperative anxiety and information scale (APAIS)
Time frame: 1 week
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 28 Oct 2024.
- Results publication: PubMed 30426190Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- Results publicationDipokromo, A., Sherman, D. W., & Lago Sr, C. (2022). Preoperative Education Regarding the Enhanced Recovery After Surgery (ERAS) Guideline for colorectal Surgical Patients: A Quality Improvement Project.
- Results publicationCarrilho, M. P. G., Pontífice-Sousa, P., & Marques, R. M. D. (2021). ERAS® Program-Nursing care for patients undergoing colorectal surgery. Acta Paulista de Enfermagem, 34, eAPE002105.
- Results publicationAbd El-Aziz E. The Effect of the Application of Clinical Pathway on Postoperative Outcomes of Patients Undergoing Percutaneous Nephrolithotomy. Alexandria University, Faculty of Nursing: Unpublished DSN dissertation. 2011.
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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 Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery and Routine hospital care in people with Colo-rectal Cancer, run by Cairo University at 1 site in Egypt.
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 1 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 28 Oct 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 Egypt. 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?
Pain Rating Scale (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660303, which also lists 4 linked publications.
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 28 Oct 2024.