Back to resultsRoutine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
Primary Purpose
Aspirin Sensitivity, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgery Without Aspirin Withdraw
Sponsored by
About this trial
This is an interventional treatment trial for Aspirin Sensitivity focused on measuring Aspirin, Minimally Invasive Thoracic Surgery, Safety
Eligibility Criteria
Inclusion Criteria:
- patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery;
- VATS and robotic surgery are both permitted;
- cardio-pulmonary function can tolerate surgery.
Exclusion Criteria:
- cardio-pulmonary function couldn't tolerate surgery;
- high bleeding risk after the pre- operative evaluation.
Sites / Locations
- The Second Hospital Of Shandong UnivercityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery Without Aspirin Withdraw
Arm Description
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
Outcomes
Primary Outcome Measures
bleeding volume
bleeding volume during surgery
surgery time
total surgery time
postoperative drainage volume
chest drainage volume after surgery
postoperative drainage duration
chest drainage duration after surgery
postoperative hospitalization time
postoperative hospitalization time
postoperative complication rate
postoperative complication rate
Secondary Outcome Measures
progression- free survival
progression- free survival
overall survival
overall survival
Full Information
NCT ID
NCT05511441
First Posted
August 19, 2022
Last Updated
August 19, 2022
Sponsor
The Second Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05511441
Brief Title
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
Official Title
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. This single- arm study was to evaluate the safety of continuous use of ASA in the perioperative period in routine minimally thoracic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin Sensitivity, Surgery
Keywords
Aspirin, Minimally Invasive Thoracic Surgery, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery Without Aspirin Withdraw
Arm Type
Experimental
Arm Description
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
Intervention Type
Procedure
Intervention Name(s)
Surgery Without Aspirin Withdraw
Intervention Description
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
Primary Outcome Measure Information:
Title
bleeding volume
Description
bleeding volume during surgery
Time Frame
on the surgery day
Title
surgery time
Description
total surgery time
Time Frame
on the surgery day
Title
postoperative drainage volume
Description
chest drainage volume after surgery
Time Frame
within 7 days after surgery
Title
postoperative drainage duration
Description
chest drainage duration after surgery
Time Frame
within 7 days after surgery
Title
postoperative hospitalization time
Description
postoperative hospitalization time
Time Frame
within 7 days after surgery
Title
postoperative complication rate
Description
postoperative complication rate
Time Frame
within 14 days after surgery
Secondary Outcome Measure Information:
Title
progression- free survival
Description
progression- free survival
Time Frame
within 5 years after surgery
Title
overall survival
Description
overall survival
Time Frame
within 10 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery;
VATS and robotic surgery are both permitted;
cardio-pulmonary function can tolerate surgery.
Exclusion Criteria:
cardio-pulmonary function couldn't tolerate surgery;
high bleeding risk after the pre- operative evaluation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Zhao
Phone
18766188692
Email
zyp_baggio@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaogang Zhao
Organizational Affiliation
The Second Hospital of Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital Of Shandong Univercity
City
Jinan
State/Province
Tianqiao
ZIP/Postal Code
250033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaogang Zhao
Phone
+8617660080007
Email
zhaoxiaogang@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
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