Effects of Early Mobilization and Feeding After Lobectomy

NCT07749950 | Active Not Recruiting

• 3 other identifiers: EGE-26-AKD-8826-AKD-8826-3/77
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

Lobectomy; Enhanced Recovery After Surgery; Early Oral Feeding; Early Mobilization; Postoperative Recovery

Outcome Measures

Primary Outcomes (4)

• Chest Tube Duration

  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.

  From surgery until chest tube removal, anticipated up to 30 days

• Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)

  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.

  Postoperative days 1, 2, and 3; 7 days after discharge; and 1 month after discharge

• Incidence and Severity of Postoperative Complications

  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.

  From surgery through 30 days after surgery

• Length of Hospital Stay

  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.

  From surgery until hospital discharge, anticipated up to 30 days

Secondary Outcomes (5)

• 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

Study Arms (2)

ERAS-Based Early Mobilization and Early Oral Feeding

EXPERIMENTAL

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.

Other: Early Mobilization; Other: Early Oral Feeding; Other: Standard Postoperative Care

Standard Postoperative Care

ACTIVE COMPARATOR

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.

Other: Standard Postoperative Care

Interventions

Early Mobilization OTHER

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.

ERAS-Based Early Mobilization and Early Oral Feeding

Early Oral Feeding OTHER

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.

ERAS-Based Early Mobilization and Early Oral Feeding

Standard Postoperative Care OTHER

Participants received the clinic's routine postoperative care following lobectomy.

ERAS-Based Early Mobilization and Early Oral Feeding; Standard Postoperative Care

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Diagnosis or suspected diagnosis of lung cancer
• Scheduled to undergo lobectomy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Voluntary agreement to participate and ability to provide informed consent

You may not qualify if:

• Requirement for emergency surgery
• Metastatic disease
• Severe uncontrolled comorbid disease, including cardiac, renal, or hepatic failure
• Requirement for mechanical ventilation for 24 hours or longer
• History of cranial trauma
• Requirement for prolonged bed rest
• Local peripheral neuropathy or central nervous system disease
• Cognitive or communication impairment

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Hospital, Department of Thoracic Surgery

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, RN

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)