Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Aspirin Sensitivity
• Intervention / Treatment: Procedure: Surgery Without Aspirin Withdraw

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunpeng Zhao; Phone Number: 18766188692; Email: zyp_baggio@163.com

Study Locations

• China
  • Tianqiao
    • Jinan, Tianqiao, China, 250033
      • Recruiting
      • The Second Hospital Of Shandong Univercity
      • Contact: Xiaogang Zhao; Phone Number: +8617660080007; Email: zhaoxiaogang@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding volume	bleeding volume during surgery	on the surgery day
surgery time	total surgery time	on the surgery day
postoperative drainage volume	chest drainage volume after surgery	within 7 days after surgery
postoperative drainage duration	chest drainage duration after surgery	within 7 days after surgery
postoperative hospitalization time	postoperative hospitalization time	within 7 days after surgery
postoperative complication rate	postoperative complication rate	within 14 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival	within 10 years after surgery
progression- free survival	progression- free survival	within 5 years after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Aspirin; Safety; Minimally Invasive Thoracic Surgery
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: Aspirin ZYP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No