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NCT04451473 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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. - Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery -

Study Design

Related Conditions & MeSH terms

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
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