Effect of Preoperative ERAS Education on Recovery After Colorectal Surgery

NCT ID: NCT07324369

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2025-10-30

Brief 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. 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ERAS-Based Preoperative Education

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.

Group Type: EXPERIMENTAL

ERAS-Based Preoperative Education

Intervention Type: BEHAVIORAL

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 Education

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.

Group Type: ACTIVE_COMPARATOR

Standard Preoperative Education

Intervention Type: BEHAVIORAL

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.

Interventions

ERAS-Based Preoperative Education

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.

Intervention Type: BEHAVIORAL

Standard Preoperative Education

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• No visual or hearing impairment
• Being conscious, cooperative, and oriented
• Hospitalized with a diagnosis of colorectal cancer
• Scheduled to undergo colorectal surgery

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir City Hospital

OTHER_GOV

Sponsor Role: collaborator

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Deniz Şanlı

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir City Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

0099

Identifier Type: -

Identifier Source: org_study_id