Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

• Sponsor: The Second Hospital of Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05511441
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aspirin Sensitivity; Surgery	Procedure: Surgery Without Aspirin Withdraw	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Without Aspirin Withdraw Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw	Procedure: Surgery Without Aspirin Withdraw; Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Outcome Measures

Primary Outcome Measures

1. bleeding volume [on the surgery day]

   bleeding volume during surgery

2. surgery time [on the surgery day]

   total surgery time

3. postoperative drainage volume [within 7 days after surgery]

   chest drainage volume after surgery

4. postoperative drainage duration [within 7 days after surgery]

   chest drainage duration after surgery

5. postoperative hospitalization time [within 7 days after surgery]

   postoperative hospitalization time

6. postoperative complication rate [within 14 days after surgery]

   postoperative complication rate

Secondary Outcome Measures

1. progression- free survival [within 5 years after surgery]

   progression- free survival

2. overall survival [within 10 years after surgery]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Hospital Of Shandong Univercity	Jinan	Tianqiao	China	250033

Sponsors and Collaborators

• The Second Hospital of Shandong University

Investigators

• Study Director: Xiaogang Zhao, The Second Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT05511441
• Other Study ID Numbers: Aspirin ZYP
• First Posted: Aug 23, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Second Hospital of Shandong University: Aspirin; Minimally Invasive Thoracic Surgery; Safety
• Additional relevant MeSH terms: Hypersensitivity; Aspirin

Study Results

No Results Posted as of Aug 23, 2022