Effect of Preoperative ERAS Education on Recovery After Colorectal Surgery

NCT07324369 | Completed

• 1 other identifier: 0099
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

enhanced recovery after surgery; colorectal cancers; colorectal surgery; patient education; preoperative care

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-40 (QoR-40) score on postoperative day 1

  The QoR-40 questionnaire assesses postoperative recovery across five domains: emotional state, physical comfort, psychological support, physical independence, and pain. Higher scores indicate better quality of recovery. Total scores range from 40 to 200, with higher scores indicating better quality of recovery.

  Postoperative day 1 (24 hours after surgery)

Secondary Outcomes (4)

• Postoperative hospital length of stay

  From the end of surgery through hospital discharge (up to 30 days)

• Total hospital length of stay

  From the day of hospital admission through hospital discharge (up to 30 days)

• Reoperation due to postoperative complications

  From the end of surgery through hospital discharge (up to 30 days)

• 30-day hospital readmission due to complication

  Within 30 days after discharge

Study Arms (2)

ERAS-Based Preoperative Education

EXPERIMENTAL

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.

Behavioral: ERAS-Based Preoperative Education

Standard Preoperative Education

ACTIVE COMPARATOR

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.

Behavioral: Standard Preoperative Education

Interventions

ERAS-Based Preoperative Education 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.

ERAS-Based Preoperative Education

Standard Preoperative Education 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.

Standard Preoperative Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Izmir City Hospital: collaborator

Study Sites (1)

Izmir City Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the statistician performing the data analysis was masked to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study used a two-arm, parallel assignment randomized controlled design. Participants were individually randomized in a 1:1 ratio to either the intervention group, which received ERAS-based preoperative education, or the control group, which received standard preoperative care. Randomization was performed using a computer-generated sequence, and allocation was concealed with sealed opaque envelopes. The study was conducted as a single-blind trial in which the outcomes assessor (statistician) was blinded to group assignment.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 7, 2026
• Study Start: January 21, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)