Effect of a Nurse-Led Early Mobilization Protocol on Colorectal Surgery Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mobility level assessed
研究概览
简要总结
This study was designed to evaluate the effectiveness of a nurse-led early mobilization protocol on postoperative recovery outcomes in patients undergoing elective colorectal surgery. The outcomes assessed include walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, incidence of postoperative complications, and length of hospital stay.
Research Question:
In patients undergoing colorectal surgery (P), does a nurse-led early mobilization protocol (I), compared with standard mobilization practices (C), improve postoperative recovery outcomes (O), including walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, postoperative complication rates, and length of hospital stay?
详细描述
Colorectal surgery is a commonly performed procedure in general surgery clinics and requires intensive postoperative nursing care. Despite advances in surgical techniques, postoperative complications such as anastomotic leakage, wound infection, paralytic ileus, and pulmonary complications remain significant challenges in patients undergoing colorectal surgery.
Enhanced Recovery After Surgery (ERAS) protocols have been developed to reduce the metabolic impact of surgical stress, accelerate recovery, and decrease postoperative complications. Early mobilization is a key component of ERAS pathways and is strongly recommended within the first 24 hours following elective colorectal surgery. Early mobilization has been shown to improve gastrointestinal function, reduce postoperative fatigue, shorten hospital length of stay, and enhance overall recovery.
However, the implementation of early mobilization in routine clinical practice is often inconsistent. Institutional constraints, patient-related physical and psychological barriers, lack of knowledge, and negative beliefs regarding mobilization may delay postoperative activity, particularly in patients undergoing colorectal surgery.
Nurses play a central role in postoperative care and are well positioned to lead, coordinate, and monitor early mobilization activities. Nurse-led, structured mobilization protocols may facilitate early mobilization by providing systematic patient education, clear activity goals, and continuous monitoring during the postoperative period.
Although nurse-led mobilization protocols have been evaluated in limited randomized controlled trials across various surgical populations, evidence specifically focused on patients undergoing colorectal surgery remains scarce.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding of participants and care providers is not feasible; however, data analysis will be performed by a statistician blinded to group assignment.
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
- •Adults aged 18 years and older
- •Scheduled for elective colorectal surgery (e.g., procedures related to
- •colorectal cancer, diverticulitis, or inflammatory bowel disease [IBD])
- •Able to ambulate independently preoperatively
- •Medically and cognitively able to participate in a mobilization protocol
- •Able to provide written informed consent
排除标准
- •Undergoing emergency colorectal surgery
- •Patients requiring postoperative intensive care unit (ICU) admission
- •Severe cognitive impairment or psychiatric disorders that may affect participation
- •Musculoskeletal or neurological conditions that impair mobility
- •Inability to understand study instructions due to language or communication barriers
研究组 & 干预措施
Nurse-Led Early Mobilization Protocol
Participants in the intervention group will receive a structured nurse-led early mobilization protocol, developed in accordance with evidence-based guidelines and current literature, in addition to standard postoperative care. As part of the protocol, patients will receive preoperative education regarding the purpose, benefits, and process of early mobilization, along with a postoperative mobilization brochure. In the postoperative period, mobilization will be initiated within the first 6-8 hours in clinically stable patients under nurse supervision. Mobilization activities will progress gradually, including in-bed exercises, sitting, assisted standing, and walking, with daily walking targets increased on postoperative days 0.-3. All mobilization activities will be delivered by nurses and documented using a standardized mobilization monitoring chart.
干预措施: Nurse-Led Early Mobilization (Other)
Standard Mobilization Care
Participants in the control group will receive standard postoperative mobilization care routinely provided in the institution. Mobilization activities will be performed according to existing clinical practices, and no structured or protocol-based nurse-led early mobilization program will be implemented. Participants in the control group will continue to receive usual nursing care without any disadvantage or additional risk in terms of patient care.
干预措施: Standard Mobilization Care (Other)
结局指标
主要结局
Mobility level assessed
时间窗: between postoperative day 0 and postoperative day 3
Patient-reported / Observer-rated Mobility Scale The Patient Mobility Scale is used to assess pain and perceived exertion experienced during the postoperative period while performing four activities: turning from one side to the other in bed, sitting at the bedside, standing up at the bedside, and walking in the patient's room. Permission to use the scale was obtained from the responsible authors. The Observer Mobility Scale evaluates the degree of patient dependence/independence during mobilization activities. Blood pressure, heart rate, and respiratory rate are measured by the observer two minutes before and after mobilization. Furthermore, the Patient- and Observer-rated Mobility Scales will be administered on postoperative days 1, 2, and 3, and the results will be documented in the monitoring form.
Total walking distance (measured by pedometer)
时间窗: between postoperative day 0 and postoperative day 3
Mobilization will be monitored using the Mobilization Monitoring Form and step counts obtained from the pedometer will be recorded at the end of each day.
Time to first flatus (hours postoperatively)
时间窗: From the end of surgery until the patient-reported first postoperative passage of flatus (within the first 72 hours postoperatively)
The time interval (in hours) from the end of surgery to the first passage of flatus reported by the patient.
Time to first defecation (hours postoperatively)
时间窗: From the end of surgery until the patient-reported first postoperative passage of defecation (within the first 72 hours postoperatively)
The time interval (in hours) from the end of surgery to the patient's first defecation will be determined and recorded based on patient self-report.
次要结局
- Postoperative nausea and vomiting (PONV)(during the first 3 postoperative days)
- Fatigue level(researcher during the first 3 postoperative days)
- Comfort level(Patients will be assessed on postoperative days 0, 1, 2, and 3.)
- Patient satisfaction(on postoperative day 3)
研究者
Nebihat Tekin
Clinical Nurse, RN
Ege University