NCT06476249

Brief Summary

Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. Pulmonary resection is the most applicable to early-stage lung cancer diagnoses and considered the best curative options. Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. This study is a prospective observational study and is expected to be carried out in a large tertiary hospital. This cohort is expected to include 1000 participants for three years. Patients with pulmonary nodules on chest CT will be divided into two groups based on the presence or absence of cough symptoms on admission. The investigators decided whether to include patients in this cohort study strictly based on the inclusion and exclusion criteria. The severity of cough, the trajectory of cough change, and the physiological and social burden caused by cough will be reflected by the results of LCQ-MC, CSS, HARQ, and VAS. LCQ-MC, CSS, HARQ, and VAS are just a few of the questionnaires that are widely used to investigate the cough and severity of the respondent. The included variables included age, gender, Height, Weight, education level, smoking history, alcohol history, preoperative lung function, nodule size, preoperative and postoperative blood routine (such as white blood cell count, neutrophil count, etc.), blood biochemistry (such as C-reactive protein, PCT, etc.), liver and kidney function test results, surgical method, surgical site, operation duration, anesthesia method, anesthesia duration, lymph node dissection, pathological results, chest tube caliber, number of days of catheterization, use of cough drugs, use of non-steroidal anti-inflammatory drugs, Number of days in hospital and number of outpatient visits due to cough.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress70%
Mar 2024May 2027

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

June 10, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

cough after pulmonary resectionthoracoscopic lung resection

Outcome Measures

Primary Outcomes (2)

  • The score value of Mandarin Chinese version of the Leicester Cough Questionnaire

    Mandarin Chinese version of the Leicester Cough Questionnaire is a globally recognized questionnaire for assessing the severity of cough

    On the 3rd,1 month and Half a year postoperatively

  • The score value of visual analogue scale

    The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough

    On the 3rd, 7th, 11th, 15th, 1 month, and half a year after surgery, respectively

Secondary Outcomes (1)

  • The score value of Hull airway reflux questionnaire

    On the 3rd,1 month and Half a year postoperatively

Study Arms (2)

cough

Patients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy with postoperative cough

Other: without

Uncough

Patients who met the inclusion and exclusion criteria and underwent thoracoscopically assisted pneumonectomy without postoperative cough

Other: without

Interventions

withoutOTHER

without

Uncoughcough

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants in this study are from the 920th Hospital. Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.

You may qualify if:

  • ● Patients aged 18 years or older and less than or equal to 70 years of age who underwent surgery with video-assisted thoracoscopic pneumonectomy.

You may not qualify if:

  • Pre-existing cough before surgery (e.g. asthma, taking ACEI Drugs, etc.)
  • Distant metastasis of tumor
  • Combined pregnancy or breastfeeding
  • Combined with other systemic major diseases (such as malignant swelling, chronic liver insufficiency, chronic renal insufficiency, etc.)
  • Suffering from mental illness
  • Refusal of follow-up or incomplete clinical information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 920th Hospital of the Joint Logistics Support Force

Kunming, Yunnan, 223964, China

RECRUITING

Related Publications (1)

  • Zhang R, Yang X, He T, Men B, Nian ZX, Yu J, Zhang YF, Liu XK, Zhang X, He GH, Cai WK. Impact of non-steroidal anti-inflammatory drugs exposure on persistent cough after pulmonary resection in a Chinese tertiary hospital: a prospective cohort study protocol. BMJ Open. 2025 Jun 30;15(6):e096934. doi: 10.1136/bmjopen-2024-096934.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wenk Cai, doctor

    the Vice-President of the 920th Hospital of the Joint Logistics Support Force

    STUDY CHAIR

Central Study Contacts

Rong Zhang, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 26, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations