Evaluation of the Effectiveness of Enhanced Recovery After Surgery (ERAS) Program in Pediatric Lung Surgery

August 13, 2026 updated by: National Taiwan University Hospital
This study aims to evaluate the clinical effectiveness of the Enhanced Recovery After Surgery (ERAS) program for pediatric lung surgery at our institution.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Using a prospective cohort design, we will observe pediatric patients undergoing lung surgery following the implementation of the ERAS program as standard practice. Outcomes will be compared with a historical control group (2014-2023) to assess whether ERAS reduces hospital length of stay, lowers postoperative complication rates, accelerates recovery, and decreases healthcare costs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients aged 0 to 18 years who underwent lung surgery at our institution. Eligible procedures were identified using treatment thoracoscopic lobectomy, thoracoscopic wedge or partial resection, and thoracoscopic segmentectomy.

Description

Inclusion Criteria:

  • Children who underwent lung surgery at our hospital's Division of Pediatric Surgery

Exclusion Criteria:

  • Patients who underwent multiple surgeries (including surgeries other than lung surgery) during the same hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Enhanced Recovery After Surgery, ERAS
During the study period, all enrolled patients will be managed according to our institution's consensus ERAS checklist for pediatric lung surgery.
Other: Enhanced Recovery After Surgery, ERAS
During the study period, all enrolled patients will be managed according to our institution's consensus checklist for pediatric lung surgery ERAS care. This includes ERAS education, preoperative assessment, fasting guidance, prophylaxis for nausea and vomiting, standardized anesthesia and surgical protocols, preference for minimally invasive surgery, multimodal postoperative analgesia, and encouragement of early oral intake and mobilization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Up to 30 days after surgery.
Number of days from index operation to hospital discharge
Up to 30 days after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Within 30 days after surgery.
Incidence of postoperative complications, including prolonged air leak, pneumonia, surgical site infection, and other procedure-related events.
Within 30 days after surgery.
Duration of urinary catheter placement
Time Frame: From date of surgery to catheter removal (up to 30 days)
Number of days with indwelling urinary catheter postoperatively.
From date of surgery to catheter removal (up to 30 days)
Duration of chest tube drainage
Time Frame: From date of surgery to chest tube removal (up to 30 days).
Number of days with thoracic drainage tube postoperatively.
From date of surgery to chest tube removal (up to 30 days).
Intensive care unit stay
Time Frame: From date of ICU admission to transfer out (up to 30 days).
Number of days in ICU after surgery.
From date of ICU admission to transfer out (up to 30 days).
Postoperative pain
Time Frame: Daily assessment up to 7 days postoperatively.
Pain intensity assessed by numeric rating scale (NRS)
Daily assessment up to 7 days postoperatively.
Postoperative analgesic use
Time Frame: Daily assessment up to 7 days postoperatively.
Total analgesic consumption.
Daily assessment up to 7 days postoperatively.
30-day readmission or emergency department visit
Time Frame: Within 30 days post-discharge.
Incidence of unplanned readmission or emergency department visit within 30 days after discharge.
Within 30 days post-discharge.
Time to resumption of oral intake
Time Frame: From date of surgery to initiation of oral intake (up to 7 days).
Interval from surgery to first tolerated oral feeding.
From date of surgery to initiation of oral intake (up to 7 days).
Hospital cost
Time Frame: From date of admission to discharge, up to 30 days
Total hospitalization cost during the index admission.
From date of admission to discharge, up to 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ERAS protocol adherence rate
Time Frame: Up to 30 days after surgery
Proportion of ERAS protocol elements implemented per patient compared to total eligible elements.
Up to 30 days after surgery
Patient satisfaction with ERAS program
Time Frame: Up to 30 days after surgery.
Satisfaction assessed by structured questionnaire at discharge.
Up to 30 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202504141RINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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