NCT07232394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 13, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

ERASlung cancervideo-assisted thoracoscopic surgerynursing care

Outcome Measures

Primary Outcomes (1)

  • The Quality of Recovery-15 (QoR-15) score

    The QoR-15 scale is a 15-item questionnaire used to assess the patient's quality of life during the postoperative recovery process, covering aspects such as pain, fatigue, anxiety, physical function, and emotional recovery. The higher the total score, the better the postoperative recovery quality.

    24 hours post-surgery.

Secondary Outcomes (7)

  • Chest Tube Placement Duration

    Perioperative.

  • Total Drainage Volume from Chest Tube

    Perioperative.

  • Postoperative Hospitalization Duration

    Perioperative.

  • Postoperative Complications

    Perioperative.

  • Total Hospitalization Costs

    Perioperative.

  • +2 more secondary outcomes

Study Arms (2)

ERAS nursing group

EXPERIMENTAL

The ERAS nursing group implements the Enhanced Recovery After Surgery (ERAS) protocol, where the medical team uses developed assessment tools to individualize the timing for each patient's first mobilization and oral intake after surgery. This intervention aims to promote postoperative recovery, reduce postoperative complications, and shorten hospital stays.

Behavioral: Traditional nursingBehavioral: ERAS protocol

Traditional nursing group

ACTIVE COMPARATOR

The traditional nursing group receives standard postoperative care, including routine nursing interventions for pain management, mobility, and nutrition.

Behavioral: Traditional nursing

Interventions

After 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.

ERAS nursing groupTraditional nursing group
ERAS protocolBEHAVIORAL

At 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.

ERAS nursing group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 75 years, with no gender restrictions;
  • Planned for elective thoracoscopic surgery, in good physical condition, able to undergo surgery and anesthesia (ASA classification no more than class III), and confirmed suitable for surgery after joint assessment by the medical and nursing team;
  • No severe cognitive impairment or mental illness, able to cooperate with nursing staff and follow intervention measures;
  • Normal function of major organs;
  • The patient has provided informed consent to participate in the study and signed the informed consent form.

You may not qualify if:

  • Patients with cognitive impairment, mental illness, or other conditions that may affect the study;
  • Requirement to convert to open surgery during the procedure;
  • Lung cancer with metastasis to other organs;
  • Failure to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 18, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations