Lung Neoplasms
Conditions
Keywords
Lobectomy, Enhanced Recovery After Surgery, Early Oral Feeding, Early Mobilization, Postoperative Recovery
Brief summary
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.
Interventions
OTHEREarly Mobilization
Participants who were hemodynamically stable and approved by the surgical team were seated at the bedside approximately 5.5 hours after surgery for 30 minutes. The first mobilization began at postoperative hour 6, during which participants walked at least 100 meters with appropriate assistance.
OTHEREarly Oral Feeding
For participants who were hemodynamically stable and approved by the surgical team, oral water intake was initiated at postoperative hour 6. If no intolerance occurred, a full liquid diet was started at hour 7, followed by a gradual transition to a regular diet at hour 12.
OTHERStandard Postoperative Care
Participants received the clinic's routine postoperative care following lobectomy.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Diagnosis or suspected diagnosis of lung cancer, including: 1. Histologically or cytologically confirmed lung cancer 2. Radiologically suspected lung cancer pending pathological confirmation * Scheduled to undergo lobectomy * Eastern Cooperative Oncology Group (ECOG) performance status of: 1. ECOG 0 2. ECOG 1 * Ability and willingness to participate, including: 1. Voluntary agreement to participate 2. Ability to provide written informed consent
Exclusion criteria
* Requirement for emergency surgery * Metastatic disease * Severe uncontrolled comorbid disease, including: 1. Cardiac failure 2. Renal failure 3. Hepatic failure * Requirement for mechanical ventilation for 24 hours or longer * History of cranial trauma * Requirement for prolonged bed rest * Neurological conditions, including: 1. Local peripheral neuropathy 2. Central nervous system disease * Impairment affecting participation, including: 1. Cognitive impairment 2. Communication impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest Tube Duration | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Hospital Readmission Within 30 Days After Discharge | Within 30 days after hospital discharge | The number and percentage of participants readmitted to a hospital for any reason within 30 days after discharge are recorded. Readmission status and reason are verified using hospital records and physician assessment and compared between the experimental and control groups. |
| Unplanned Reoperation Within 30 Days After Surgery | From surgery through 30 days after surgery | The number and percentage of participants requiring an unplanned repeat surgical procedure due to a postoperative complication are recorded using hospital records and physician assessment. Reoperation rates are compared between the experimental and control groups. |
| Change in Quality of Life Assessed Using the EORTC QLQ-C30 | Preoperative baseline and 1 and 3 months after hospital discharge | Quality of life is assessed using the 30-item EORTC QLQ-C30 questionnaire. Scale scores are transformed to a range from 0 to 100. Higher global health and functional scale scores indicate better quality of life and functioning, whereas higher symptom scale scores indicate greater symptom burden. Changes from the preoperative assessment are compared between the experimental and control groups. |
| Change in Lung Cancer-Specific Symptoms Assessed Using the EORTC QLQ-LC13 | Preoperative baseline and 1 and 3 months after hospital discharge | Lung cancer-specific symptoms and treatment-related effects are assessed using the 13-item EORTC QLQ-LC13 questionnaire. Scores are transformed to a range from 0 to 100, with higher scores indicating greater symptom burden. Changes from the preoperative assessment are compared between the experimental and control groups. |
| Change in Nutritional Risk Assessed Using the NRS-2002 | Preoperative baseline and 7 days after hospital discharge | Nutritional risk is assessed using the Nutritional Risk Screening 2002 (NRS-2002). The total score ranges from 0 to 7, with higher scores indicating greater nutritional risk. A score of 3 or higher indicates that the participant is at nutritional risk. Changes from the preoperative score are compared between the experimental and control groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed