Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT07232394
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feeding and Mobilization in Thoracic Surgery
Sponsor:
Jianxing He
Organization:
Study Overview
Official Title:
The Impact of Early Feeding and Mobilization on Rehabilitation in Thoracic Surgery: A Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: