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

Not Applicable

Recruiting

• Conditions: ERAS; Lung Cancer; Surgery
• Interventions: Procedure: Traditional perioperative management without Enhanced Recovery After Surgery (ERAS ); Procedure: Enhanced Recovery After Surgery (ERAS )

• Registration Number: NCT04451473
• Lead Sponsor: The Second Hospital of Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-27
• Study First Posted: 2020-06-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16
• Primary Completion: 2023-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control- Group	Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )	Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS).
ERAS- Group	Enhanced Recovery After Surgery (ERAS )	Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS).

Primary Outcome Measures

Name	Time	Method
the degree of pain	within 4 days after surgery	Visual Analogue Scale/Score
intensive care unit utilization	within 4 days after surgery	the time in intensive care unit utilization
the time of ambulation	within 48 hours after surgery	the time after surgery that patients could leave the bed and walk
the time for oral feed	within 48 hours after surgery	the time for oral feed
the time of hospitalization	within 5 days after surgery	the time of hospitalization
complications	within 7 days after surgery	the rate of complications

Secondary Outcome Measures

Name	Time	Method
disease- free survival	within 5 years after surgery	disease- free survival
overall survival	within 10 years after surgery	overall survival

Trial Locations

Locations (1)

Yunpeng Zhao; 🇨🇳 Jinan, Shandong, China