The Effect of Preoperative Education Based on ERAS Protocols on Postoperative Recovery in Patients Undergoing Colorectal Surgery: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Izmir Katip Celebi University
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Quality of Recovery-40 (QoR-40) score on postoperative day 1
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the statistician performing the data analysis was masked to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ERAS-Based Preoperative Education (Behavioral)
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.
干预措施: Standard Preoperative Education (Behavioral)
结局指标
主要结局
Quality of Recovery-40 (QoR-40) score on postoperative day 1
时间窗: Postoperative day 1 (24 hours after surgery)
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.
次要结局
- 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)
研究者
Deniz Şanlı
Assistant Professor
Izmir Katip Celebi University