- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07288710
A Study to Explore the Early Subjective Evaluation and Objective Recovery in Lung Cancer Patients Undergoing Sublobar Resection Versus Lobectomy
December 15, 2025 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
A Prospective Observational Study to Explore the Early Subjective Evaluation and Objective Recovery in Lung Cancer Patients Undergoing Sublobar Resection Versus Lobectomy
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 Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianxing He, M.D.
- Phone Number: +86-20-83337792
- Email: drjianxing.he@gmail.com
Study Contact Backup
- Name: Hengrui Liang, M.D.
- Phone Number: +86-20-83062114
- Email: liang_hengrui@163.com
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University
-
Contact:
- Hengrui Liang, M.D.
- Phone Number: +86-020-83062807
- Email: liang_hengrui@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients with histopathologically confirmed lung cancer were consecutively recruited
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Sublobar Resection Group
Patients in this group underwent sublobar resection (including segmentectomy or wedge resection).
The decision for patients to receive this surgical procedure was similarly based on their routine clinical assessment, disease characteristics, physician's recommendation, and informed consent.
It was not a result of randomization or active intervention by the investigators.
This study will prospectively observe the post-operative recovery and prognosis of these patients, comparing them to the lobectomy group.
|
|
Lobectomy Group
Patients in this group underwent standard lobectomy.
The decision for patients to receive this surgical procedure was based on their routine clinical assessment, diagnosis, disease staging, physician's recommendation, and informed consent.
It was not a result of randomization or active intervention by the investigators.
This study will prospectively observe the post-operative recovery and prognosis of these patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From 1 day prior to surgery through hospital discharge (assessed up to 15 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay
Time Frame: From the day of surgery until the day of discharge, assessed up to 15 days.
|
Total number of days spent in the hospital from admission to discharge.
|
From the day of surgery until the day of discharge, assessed up to 15 days.
|
|
Surgical Time
Time Frame: During the surgical procedure (from anesthesia induction until skin closure).
|
Duration of the surgery measured in hours.
|
During the surgical procedure (from anesthesia induction until skin closure).
|
|
Number of Lymph Nodes Dissected
Time Frame: During the surgical procedure (from anesthesia induction until skin closure).
|
The total count of lymph nodes harvested during the surgical procedure.
|
During the surgical procedure (from anesthesia induction until skin closure).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2023
Primary Completion (Estimated)
December 10, 2025
Study Completion (Estimated)
April 20, 2026
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
December 15, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMU-LC-202511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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