Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Surgery Clinical Trial

Official title:

Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511441
• Other study ID #: Aspirin ZYP
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: August 2022
• Source: The Second Hospital of Shandong University
• Contact: Yunpeng Zhao
• Phone: 18766188692
• Email: zyp_baggio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery;

2. VATS and robotic surgery are both permitted;

3. cardio-pulmonary function can tolerate surgery.

Exclusion Criteria:

1. cardio-pulmonary function couldn't tolerate surgery;

2. high bleeding risk after the pre- operative evaluation.

Related Conditions & MeSH terms

• Aspirin Sensitivity
• Hypersensitivity
• Surgery

Intervention

Procedure:
• Surgery Without Aspirin Withdraw
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Locations

Country	Name	City	State
China	The Second Hospital Of Shandong Univercity	Jinan	Tianqiao

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	bleeding volume	bleeding volume during surgery	on the surgery day
Primary	surgery time	total surgery time	on the surgery day
Primary	postoperative drainage volume	chest drainage volume after surgery	within 7 days after surgery
Primary	postoperative drainage duration	chest drainage duration after surgery	within 7 days after surgery
Primary	postoperative hospitalization time	postoperative hospitalization time	within 7 days after surgery
Primary	postoperative complication rate	postoperative complication rate	within 14 days after surgery
Secondary	progression- free survival	progression- free survival	within 5 years after surgery
Secondary	overall survival	overall survival	within 10 years after surgery