CClinicalTrials.gg
CompletedNCT06660303Updated Oct 28, 2024

Preoperative Patient Education for Enhanced Recovery After Colon and Rectal Surgery

An interventional study of Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery and Routine hospital care in Colo-rectal Cancer, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

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.

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Conditions studied

  • Colo-rectal Cancer

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Keywords

  • Preoperative Education
  • Nursing Intervention
  • Enhanced Recovery After Surgery (ERAS)
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 100 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult male and female patients with colon cancer undergoing colorectal surgery via colonoscope.

Exclusion criteria

Exclusion Criteria:

  • patients with open surgery.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Study group

    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.

    Behavioral: Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery

  • Active comparator
    Control Group

    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

    Other: Routine hospital care

Interventions

  • BehavioralComprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery

    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.

  • OtherRoutine hospital care

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 1 week

Other outcomes

  1. Colorectal Surgical Patient's Satisfaction tool

    Likert scale ranging from 1 to 3; a score(1) dissatisfied, (2) neutral, (3) satisfied. The total score value ranged between 15 - 45. The higher the score the higher the patient's satisfaction level. This tool was adopted from Salisbury et al., (2005). It was translated to Arabic language and tested for validity and reliability by Abd El-Aziz, (2011). Its internal consistency reliability was (r = 0.840).

    Time frame: 1 week

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Study locations

1 site
  • Faculy of Nursing Cairo University
    Cairo, Giza 11562, Egypt
08

References and documents

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 30426190 ↗
  • Dipokromo, 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06660303
Lead sponsor
Cairo University
Responsible party
Mohammed Elsayed Zaky (Principal Investigator, Cairo University) — Principal investigator
First posted
Oct 28, 2024
Start date
Jul 30, 2024
Primary completion
Sep 1, 2024
Completion
Oct 22, 2024
Last update
Oct 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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