Lung Surgery With Enhanced Recovery VS. Lung Surgery Without Enhanced Recovery

Lung Cancer Clinical Trial

Official title:

The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451473
• Other study ID #: ERAS ZYP
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2022
• Source: The Second Hospital of Shandong University
• Contact: Yunpeng Zhao, Doctor
• Phone: 17660081916
• Email: zhaoyunpengsddx[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer.

Methods: A Randomized Controlled Trial was designed to collect the perioperative data on consecutive patients undergoing lung resection for primary lung cancer. Patients will be randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect will be compared between the two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria: patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need VATS surgery.

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Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery

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Related Conditions & MeSH terms

• ERAS
• Lung Cancer
• Surgery

Intervention

Procedure:
• Enhanced Recovery After Surgery (ERAS )
the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS
• Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )
the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery

Locations

Country	Name	City	State
China	Yunpeng Zhao	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensive care unit utilization	the time in intensive care unit utilization	within 4 days after surgery
Primary	the degree of pain	Visual Analogue Scale/Score	within 4 days after surgery
Primary	the time of ambulation	the time after surgery that patients could leave the bed and walk	within 48 hours after surgery
Primary	the time for oral feed	the time for oral feed	within 48 hours after surgery
Primary	the time of hospitalization	the time of hospitalization	within 5 days after surgery
Primary	complications	the rate of complications	within 7 days after surgery
Secondary	disease- free survival	disease- free survival	within 5 years after surgery
Secondary	overall survival	overall survival	within 10 years after surgery