NCT06660303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 24, 2024

Last Update Submit

October 25, 2024

Conditions

Keywords

Preoperative EducationNursing InterventionEnhanced Recovery After Surgery (ERAS)

Outcome Measures

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.

    1 week

Secondary Outcomes (1)

  • Amsterdam preoperative anxiety and information scale (APAIS)

    1 week

Other Outcomes (1)

  • Colorectal Surgical Patient's Satisfaction tool

    1 week

Study Arms (2)

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.

Behavioral: Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery

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

Other: Routine hospital care

Interventions

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.

Study group

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.

Control Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with open surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculy of Nursing Cairo University

Cairo, Giza Governorate, 11562, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 30426190BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

July 30, 2024

Primary Completion

September 1, 2024

Study Completion

October 22, 2024

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations