Preoperative Patient Education for Enhanced Recovery After Colon and Rectal Surgery

October 25, 2024 updated by: Mohammed Elsayed Zaky, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 11562
        • Faculy of Nursing Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with open surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amsterdam preoperative anxiety and information scale (APAIS)
Time Frame: 1 week
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.
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal Surgical Patient's Satisfaction tool
Time Frame: 1 week
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).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

October 22, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Preoperative Patient Education

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colo-rectal Cancer

Clinical Trials on Comprehensive Preoperative Education for Enhanced Recovery in Colorectal Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe