Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
688

Summary

Conditions
  • Lung Neoplasms
  • Surgery
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the ...

Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial. The following rules will be strictly applied: The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted. If the Eligibility Application Form is incomplete, it must be returned to be completed; otherwise, it will not be accepted. After being approved by the Research Committee, the case will be assigned a number (Baseline Number, BN) and an Eligibility Confirmation Notice will be sent to the applicant. After each research participating center receives the Eligibility Confirmation Notice, the research assistant of each center is responsible for the custody and documentation. Once being selected for registration, the content of the Eligibility Application Form will be input into the database and the case's eligibility is not allowed to be cancelled, that is, the relevant information cannot be deleted from the database, unless the patient declines the information to be used in this study. The data center will not accept any duplicated applications for any single case. If this happens, the first registered data will be used (i.e., the first time BN). In cases of duplicated applications or registration errors, the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation. Qualification of the responsible surgeons who participate in this study: the responsible surgeons who participate in this study shall meet the following qualifications: 1) at least have completed 20 cases of VATS segmentectomy; and 2) have passed the blind review of his/her video records of the surgery. Criteria for confirming operation quality: for the case to be included in the analysis, the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures. Rules for handling the excluded patients identified intraoperatively: if the responsible surgeon finds that the patient in operation meets the exclusion criteria, the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol.

Tracking Information

NCT #
NCT02718365
Collaborators
Not Provided
Investigators
Principal Investigator: Lunxu Liu, M.D., Ph.D. Department of Thoracic Surgery, West China Hospital, Sichuan University