The Effect of Early Nutrition and Mobilization From ERAS Protocols on Patient Outcomes in Lung Cancer Patients Undergoing Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Chest Tube Duration
研究概览
简要总结
This randomized controlled study evaluates the effects of early mobilization and early oral feeding, two components of the Enhanced Recovery After Surgery (ERAS) protocol, on postoperative outcomes in adult patients with lung cancer undergoing lobectomy at Ege University Hospital.
Participants were randomly assigned to an intervention group or a control group. In addition to standard postoperative care, participants in the intervention group received an ERAS-based protocol consisting of sitting at the bedside approximately 5.5 hours after surgery, beginning mobilization at 6 hours, and walking at least 100 meters when clinically stable and approved by the surgical team. Oral water intake was started at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated. Participants in the control group received the clinic's standard postoperative care.
The study compares postoperative pain, complications, chest tube duration, length of hospital stay, reoperation, readmission within 30 days, nutritional status, laboratory findings, and quality of life between the two groups. Participants are followed for up to three months after surgery.
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
- None
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
- •Age 18 years or older
- •Diagnosis or suspected diagnosis of lung cancer, including:
- •Histologically or cytologically confirmed lung cancer
- •Radiologically suspected lung cancer pending pathological confirmation
- •Scheduled to undergo lobectomy
- •Eastern Cooperative Oncology Group (ECOG) performance status of:
- •Ability and willingness to participate, including:
- •Voluntary agreement to participate
- •Ability to provide written informed consent
排除标准
- •Requirement for emergency surgery
- •Metastatic disease
- •Severe uncontrolled comorbid disease, including:
- •Cardiac failure
- •Renal failure
- •Hepatic failure
- •Requirement for mechanical ventilation for 24 hours or longer
- •History of cranial trauma
- •Requirement for prolonged bed rest
- •Neurological conditions, including:
- •Local peripheral neuropathy
- •Central nervous system disease
- •Impairment affecting participation, including:
- •Cognitive impairment
- •Communication impairment
研究组 & 干预措施
ERAS-Based Early Mobilization and Early Oral Feeding
Participants received the clinic's standard postoperative care plus an ERAS-based early mobilization and oral feeding protocol. When hemodynamically stable and with approval from the surgical team, participants sat at the bedside approximately 5.5 hours after surgery for 30 minutes, began mobilization at 6 hours, and walked at least 100 meters. Oral water intake began at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated.
干预措施: Early Oral Feeding (Other)
ERAS-Based Early Mobilization and Early Oral Feeding
Participants received the clinic's standard postoperative care plus an ERAS-based early mobilization and oral feeding protocol. When hemodynamically stable and with approval from the surgical team, participants sat at the bedside approximately 5.5 hours after surgery for 30 minutes, began mobilization at 6 hours, and walked at least 100 meters. Oral water intake began at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated.
干预措施: Early Mobilization (Other)
ERAS-Based Early Mobilization and Early Oral Feeding
Participants received the clinic's standard postoperative care plus an ERAS-based early mobilization and oral feeding protocol. When hemodynamically stable and with approval from the surgical team, participants sat at the bedside approximately 5.5 hours after surgery for 30 minutes, began mobilization at 6 hours, and walked at least 100 meters. Oral water intake began at 6 hours, followed by a full liquid diet at 7 hours and gradual transition to a regular diet at 12 hours if tolerated.
干预措施: Standard Postoperative Care (Other)
Standard Postoperative Care
Participants received the clinic's standard postoperative care without the additional ERAS-based early mobilization and early oral feeding protocol. Routine care included postoperative monitoring, oxygen support as required, assessment of vital signs, drainage, respiratory function and pain, and coughing and breathing exercises. A liquid diet was initiated at 06:00 on the morning after surgery, and mobilization was performed according to the participant's hemodynamic condition and approval from the surgical team.
干预措施: Standard Postoperative Care (Other)
结局指标
主要结局
Chest Tube Duration
时间窗: From surgery until chest tube removal, anticipated up to 30 days
The duration of chest tube placement is measured in days from the date of surgery until chest tube removal. The mean duration is compared between the experimental and control groups using hospital records.
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
时间窗: Postoperative days 1, 2, and 3; 7 days after discharge; and 1 month after discharge
Pain intensity is assessed using a 100-mm Visual Analog Scale, where 0 mm indicates no pain and 100 mm indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Scores are compared between the experimental and control groups at each assessment time point.
Incidence and Severity of Postoperative Complications
时间窗: From surgery through 30 days after surgery
The number and percentage of participants who develop one or more postoperative complications, including prolonged air leak lasting 7 days or more, atelectasis, pneumonia, chylothorax, atrial fibrillation, or postoperative bleeding. Complication severity is graded according to the Clavien-Dindo classification.
Length of Hospital Stay
时间窗: From surgery until hospital discharge, anticipated up to 30 days
Length of hospital stay is measured in days from the date of surgery until hospital discharge. The mean duration is compared between the experimental and control groups using hospital records.
次要结局
- All-Cause Hospital Readmission Within 30 Days After Discharge(Within 30 days after hospital discharge)
- Unplanned Reoperation Within 30 Days After Surgery(From surgery through 30 days after surgery)
- Change in Quality of Life Assessed Using the EORTC QLQ-C30(Preoperative baseline and 1 and 3 months after hospital discharge)
- Change in Lung Cancer-Specific Symptoms Assessed Using the EORTC QLQ-LC13(Preoperative baseline and 1 and 3 months after hospital discharge)
- Change in Nutritional Risk Assessed Using the NRS-2002(Preoperative baseline and 7 days after hospital discharge)