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Clinical Trials/NCT07288710
NCT07288710
Recruiting
Not Applicable

A Prospective Observational Study to Explore the Early Subjective Evaluation and Objective Recovery in Lung Cancer Patients Undergoing Sublobar Resection Versus Lobectomy

The First Affiliated Hospital of Guangzhou Medical University1 site in 1 country300 target enrollmentStarted: March 9, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Enrollment
300
Locations
1
Primary Endpoint
Electronic patient-reported outcomes

Overview

Brief Summary

The trial was designed as a single-center, non-interventional, prospective observational study to explore the role of a multimodal digital device in analyzing subjective and objective recovery in lung cancer patients undergoing sublobar resection versus lobectomy.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • adult patients (age ≥ 18 years)
  • American Society of Anesthesiologists (ASA) grade of III or below
  • scheduled for VATS from March to December 2023

Exclusion Criteria

  • age \<18 years
  • inability or poor compliance to use wearable devices
  • lack of smartphone
  • incomplete digital device data during hospitalization
  • patients with lymph node or distant metastasis

Outcomes

Primary Outcomes

Electronic patient-reported outcomes

Time Frame: From 1 day prior to surgery through hospital discharge (assessed up to 15 days).

The electronic patient-reported outcomes questionnaire includes pain, cough, shortness of breath, restless sleep, fatigue, drowsiness, walking difficulties, activity limitation, and distress(0 = no symptom, 10 = most severe).

Secondary Outcomes

  • Number of Lymph Nodes Dissected(During the surgical procedure (from anesthesia induction until skin closure).)
  • Length of Hospital Stay(From the day of surgery until the day of discharge, assessed up to 15 days.)
  • Surgical Time(During the surgical procedure (from anesthesia induction until skin closure).)

Investigators

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jianxing He

Professor

The First Affiliated Hospital of Guangzhou Medical University

Study Sites (1)

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