- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241286
Evaluation of the Effectiveness of Enhanced Recovery After Surgery (ERAS) Program in Pediatric Lung Surgery
November 16, 2025 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
Enrolling by invitation
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
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Taipei, Taiwan, Taiwan
- National Taiwan University Hospital
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-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
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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
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
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.
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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).
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Number of days with thoracic drainage tube postoperatively.
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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).
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Number of days in ICU after surgery.
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From date of ICU admission to transfer out (up to 30 days).
|
|
Postoperative pain
Time Frame: Daily assessment up to 7 days postoperatively.
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Pain intensity assessed by numeric rating scale (NRS)
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Daily assessment up to 7 days postoperatively.
|
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Postoperative analgesic use
Time Frame: Daily assessment up to 7 days postoperatively.
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Total analgesic consumption.
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Daily assessment up to 7 days postoperatively.
|
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30-day readmission or emergency department visit
Time Frame: Within 30 days post-discharge.
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Incidence of unplanned readmission or emergency department visit within 30 days after discharge.
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Within 30 days post-discharge.
|
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Time to resumption of oral intake
Time Frame: From date of surgery to initiation of oral intake (up to 7 days).
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Interval from surgery to first tolerated oral feeding.
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From date of surgery to initiation of oral intake (up to 7 days).
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Hospital cost
Time Frame: From date of admission to discharge, up to 30 days
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Total hospitalization cost during the index admission.
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From date of admission to discharge, up to 30 days
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Other Outcome Measures
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.
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Up to 30 days after surgery
|
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Patient satisfaction with ERAS program
Time Frame: Up to 30 days after surgery.
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Satisfaction assessed by structured questionnaire at discharge.
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Up to 30 days after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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)
June 5, 2025
Primary Completion (Estimated)
February 28, 2030
Study Completion (Estimated)
February 28, 2030
Study Registration Dates
First Submitted
October 2, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 21, 2025
Study Record Updates
Last Update Posted (Actual)
November 21, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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