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NCT Number: NCT07749950

Effects of Early Mobilization and Feeding After Lobectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Hospital, Department of Thoracic Surgery

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • ECOG 0
  • ECOG 1
  • Ability and willingness to participate, including:
  • Voluntary agreement to participate
  • Ability to provide written informed consent

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Standard Postoperative Care

Other

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

Primary outcomes

  1. Chest Tube Duration

    Time frame: 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.

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

    Time frame: 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.

  3. Incidence and Severity of Postoperative Complications

    Time frame: 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.

  4. Length of Hospital Stay

    Time frame: 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 outcomes

  1. All-Cause Hospital Readmission Within 30 Days After Discharge

    Time frame: 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.

  2. Unplanned Reoperation Within 30 Days After Surgery

    Time frame: 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.

  3. Change in Quality of Life Assessed Using the EORTC QLQ-C30

    Time frame: 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.

  4. Change in Lung Cancer-Specific Symptoms Assessed Using the EORTC QLQ-LC13

    Time frame: 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.

  5. Change in Nutritional Risk Assessed Using the NRS-2002

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Early Nutrition and Mobilization From ERAS Protocols on Patient Outcomes in Lung Cancer Patients Undergoing Lobectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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