Clinical Trials Directory

Trials / Completed

CompletedNCT07232394

Early Feeding and Mobilization in Thoracic Surgery

The Impact of Early Feeding and Mobilization on Rehabilitation in Thoracic Surgery: A Prospective Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
232 (actual)
Sponsor
Jianxing He · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This study evaluates the safety and effectiveness of an innovative care assessment tool for early feeding and mobilization following thoracic surgery, based on the Enhanced Recovery After Surgery (ERAS) protocol. The aim is to improve postoperative recovery by helping healthcare providers implement a structured, evidence-based plan for early feeding and activity. The study will compare the new care model (ERAS-based) with traditional postoperative care. The investigators will focus on outcomes like recovery quality, complications, hospital stay, and medication use. This research aims to provide solid evidence for integrating early feeding and mobilization into routine thoracic surgery recovery, potentially improving patient comfort, reducing recovery time, and lowering complications.

Detailed description

Lung cancer remains the leading cause of cancer-related morbidity and mortality worldwide. Surgery, especially for early and intermediate-stage patients, is considered the cornerstone of treatment. With the advancement of minimally invasive techniques, such as video-assisted thoracic surgery (VATS), the degree of surgical trauma and the risk of complications have significantly decreased. However, despite these innovations, postoperative complications still occur in 30%-40% of patients, indicating that improvements in surgical techniques alone are insufficient to eliminate perioperative risks. In response, the Enhanced Recovery After Surgery (ERAS) protocol has been introduced in thoracic surgery to optimize postoperative recovery. ERAS strategies have shown promising results in reducing complications, pain medication use, and hospital stays. However, most of the clinical evidence supporting ERAS comes from colorectal surgery, with limited research focusing on its application in thoracic surgery. Further validation of its safety, feasibility, and effectiveness in thoracic surgery patients is urgently needed. One core element of ERAS in thoracic surgery is early postoperative oral feeding. Traditional postoperative management often restricts food and fluids for 4-6 hours to reduce the risk of nausea and vomiting caused by residual anesthesia, but this restriction can lead to discomfort from thirst and hunger. Restoring oral intake as early as possible, provided there is no high aspiration risk and vital signs are stable, has been shown to enhance comfort and recovery. However, clinical implementation of early feeding has been suboptimal, and most related studies have focused on gastrointestinal surgeries. Evidence supporting early feeding in thoracic surgery is still lacking. In addition to early feeding, early mobilization is another key component of ERAS in thoracic surgery. As the ERAS concept evolves, research has increasingly focused on multi-faceted interventions, suggesting that combining early feeding and mobilization could have a synergistic effect in optimizing postoperative outcomes. Despite this potential, high-quality evidence supporting this combined strategy in thoracic surgery is still limited. Given these challenges, this study aims to evaluate the safety and effectiveness of a newly developed, time-point-based nursing assessment tool for early feeding and mobilization after thoracic surgery. This single-center, randomized, single-blind, parallel-controlled trial will assess the tool's impact on patient outcomes, including recovery quality, complications, and hospital stay. The ultimate goal is to provide evidence for the clinical adoption and implementation of this tool in thoracic surgery recovery, enhancing patient recovery and contributing to the broader application of ERAS principles in this field.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTraditional nursingAfter the patient is admitted, the nursing team conducts a comprehensive assessment, including blood glucose, blood pressure, medication history, smoking history, alcohol consumption history, etc., to develop the patient's care plan. Preoperatively, the nursing staff will educate the patient about perioperative knowledge and inform the patient about fasting and withholding fluids 8 hours before the surgery. Postoperatively, the nursing staff closely monitors the patient's vital signs, surgical wounds, and drainage, and provides relevant health education. According to medical orders, the nursing team will guide the patient in appropriate eating and activity, and use medications to address postoperative discomfort.
BEHAVIORALERAS protocolAt 0, 2, and 4 hours postoperatively, the nursing team will progressively assess the patient's condition in the order of vital signs, consciousness, nausea and vomiting severity, swallowing function, pain score, and muscle strength. If all the assessment results meet the criteria, the nursing staff will guide the patient to try eating a small amount of liquid food and maintain the head of the bed elevated to a 30-degree angle. At the same time, the nursing staff will guide the patient to follow a progressive activity regimen, starting with sitting up in bed for 3 minutes, then sitting at the bedside for 3 minutes, followed by standing at the bedside for 3 minutes. If there is no discomfort, the patient may walk moderately within the ward.

Timeline

Start date
2025-01-01
Primary completion
2025-06-01
Completion
2025-09-01
First posted
2025-11-18
Last updated
2025-11-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07232394. Inclusion in this directory is not an endorsement.