Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery

NCT ID: NCT06016881

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-18

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Lung cancer has been the most commonly diagnosed cancer globally over the past few decades. Histologically, adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are defined as cancers with no or limited tissue infiltration. Studies have shown that patients with AIS or MIA have a 100% probability of being free of recurrence within 5 years after surgery and have disease-specific survival rates of 100% and 100%, respectively.

In patients with early-stage lung cancer and benign lesions, long-term postoperative survival and tumor recurrence are non-priorities. Therefore, perioperative and postoperative quality of life are increasingly emphasized by patients and clinicians. However, a significant proportion of patients undergoing minimally invasive lung surgery still develop chronic pain and chronic cough in the postoperative period, the severity of which can lead to reduced quality of life. In addition, studies of the psychological state of patients undergoing surgery for pulmonary nodules are rare, and we believe this is one of the valuable factors affecting quality of life. The investigators have launched the first prospective observational trial to investigate the incidence of long-term chronic symptoms after minimally invasive lung surgery, risk factors, treatment received and treatment efficacy, duration of disease, and eventual regression, in addition to pre- and postoperative psychological status and long-term postoperative quality of life in patients undergoing minimally invasive lung surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lung cancer has been the most commonly diagnosed cancer globally over the past few decades. With the widespread use of Low-dose computedtomograph (LDCT), more and more lung nodules are being detected. With the exception of benign nodules, the vast majority of lung cancer nodules are early stage lung cancers with predominantly ground glass lesions. Histologically, adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are defined as cancers with no or limited tissue infiltration. Studies have shown that patients with AIS or MIA have a 100% probability of being free of recurrence within 5 years after surgery and have disease-specific survival rates of 100% and 100%, respectively.

In patients with early-stage lung cancer and benign lesions, long-term postoperative survival and tumor recurrence are non-priorities. Therefore, perioperative and postoperative quality of life are increasingly emphasized by patients and clinicians. Enhanced rapid recovery management after video-assisted thoracoscopic surgery (VATS) can minimize the damage and impact of surgery on patients. However, a significant proportion of patients undergoing minimally invasive lung surgery still develop chronic pain and chronic cough in the postoperative period, the severity of which can lead to reduced quality of life. In addition, studies of the psychological state of patients undergoing surgery for pulmonary nodules are rare, and we believe this is one of the valuable factors affecting quality of life. The investigators have launched the first prospective observational trial to investigate the incidence of long-term chronic symptoms after minimally invasive lung surgery, risk factors, treatment received and treatment efficacy, duration of disease, and eventual regression, in addition to pre- and postoperative psychological status and long-term postoperative quality of life in patients undergoing minimally invasive lung surgery.

The researchers included patients with stage I lung cancer and benign lesions who underwent single-port thoracoscopic lung surgery. Patients' baseline levels, including usual chronic pain, chronic cough, and sleep, were recorded prior to surgery, and anxiety, depression, and quality of life scores were performed using the Generalized Anxiety Disorder Screener (GAD-7), Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale (HADS), and the European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30). For the first 3 days after surgery, Pain, cough, nausea and vomiting were assessed using the numeric pain rating scale (NRS) and the visual simulation scale (VAS) score 3 times a day (every 8 hours), and sleep status were recorded each day. Anxiety and depression were evaluated during postoperative hospital stay. Postoperative chronic symptoms and quality of life will be assessed at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough will be assessed using the Leicester Cough Questionnaire, chronic pain will be assessed using Brief Pain Inventory and McGill Pain Questionnaire, and EORTC QLQ-C30 questionnaire, HADS, GAD-7 and BDI for continuous assessment of quality of life, anxiety status and depression status, as well as to record the time of onset of chronic symptoms, predisposing factors, aggravating and relieving factors, the presence or absence of treatment, the effectiveness of the treatment, and time of exacerbation, remission or disappearance.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Stage I Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18 years or above;
2. Received single-port thoracoscopic surgery;
3. Diagnosed with stage I lung cancer or benign lesions by histologic examination;
4. Volunteered to participate in the study and signed an informed consent form.

Exclusion Criteria

1. Previous thoracic surgery
2. Any type of chronic pain, requiring daily use of analgetics
3. Any type of chronic cough that requires daily medication
4. pregnant
5. Breast feeding
6. contraindications to NSAID
7. Combination of other tumors requiring chemotherapy or radiotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fujian Medical University Union Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maohui Chen

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maohui Chen

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maohui Chen

Role: CONTACT

+8618659181171

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maohui Chen

Role: primary

18659181171

References

Explore related publications, articles, or registry entries linked to this study.

Huang Y, Chen M, Wu Z, Liu P, Zhang S, Chen C, Zheng B. Postoperative chronic operation-related symptoms after minimally invasive lung surgery: a prospective observational protocol. BMJ Open. 2024 Aug 3;14(8):e082412. doi: 10.1136/bmjopen-2023-082412.

Reference Type DERIVED
PMID: 39097304 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

POSLS-union01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Perioperative Treatment Outcomes of Early NSCLC
NCT06610240 ENROLLING_BY_INVITATION
Survival Outcomes of Lung Cancer
NCT03647098 RECRUITING