NCT05511441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 19, 2022

Last Update Submit

August 19, 2022

Conditions

Aspirin SensitivitySurgery

Keywords

AspirinMinimally Invasive Thoracic SurgerySafety

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • progression- free survival

    within 5 years after surgery

  • overall survival

    within 10 years after surgery

Study Arms (1)

Surgery Without Aspirin Withdraw

EXPERIMENTAL

Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Procedure: Surgery Without Aspirin Withdraw

Interventions

Surgery Without Aspirin WithdrawPROCEDURE

Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw

Surgery Without Aspirin Withdraw

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • cardio-pulmonary function couldn't tolerate surgery;
  • high bleeding risk after the pre- operative evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital Of Shandong Univercity

Jinan, Tianqiao, 250033, China

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Xiaogang Zhao

    The Second Hospital of Shandong University

    STUDY DIRECTOR

Central Study Contacts

Yunpeng Zhao

CONTACT

18766188692zyp_baggio@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 23, 2022

Study Start

June 1, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2025

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

CN(1)