Lung Surgery With Enhanced Recovery VS. Lung Surgery Without Enhanced Recovery
The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery
1 other identifier
interventional
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Oct 2019
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2019
CompletedFirst Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedNovember 16, 2022
February 1, 2022
3.7 years
June 27, 2020
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
intensive care unit utilization
the time in intensive care unit utilization
within 4 days after surgery
the degree of pain
Visual Analogue Scale/Score
within 4 days after surgery
the time of ambulation
the time after surgery that patients could leave the bed and walk
within 48 hours after surgery
the time for oral feed
the time for oral feed
within 48 hours after surgery
the time of hospitalization
the time of hospitalization
within 5 days after surgery
complications
the rate of complications
within 7 days after surgery
Secondary Outcomes (2)
disease- free survival
within 5 years after surgery
overall survival
within 10 years after surgery
Study Arms (2)
ERAS- Group
EXPERIMENTALPatients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS).
Control- Group
OTHERPatients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS).
Interventions
the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS
the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yunpeng Zhao
Jinan, Shandong, 250033, China
Related Publications (1)
Ding Y, Zhou L, Shan L, Zhang W, Li P, Cong B, Tian Z, Zhao Y, Zhao X. Video- assisted thoracoscopic lung resection with or without enhanced recovery after surgery: a single institution, prospective randomized controlled study. Front Oncol. 2024 Nov 8;14:1474438. doi: 10.3389/fonc.2024.1474438. eCollection 2024.
PMID: 39582544DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaogang Zhao, Doctor
The Second Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
June 30, 2020
Study Start
October 8, 2019
Primary Completion
June 30, 2023
Study Completion (Estimated)
June 30, 2027
Last Updated
November 16, 2022
Record last verified: 2022-02