Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery

Quality of Life Clinical Trial

Official title:

Prospective Observational Study of Postoperative Chronic Operation-related Symptoms and Long-term Survival Quality After Minimally Invasive Lung Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016881
• Other study ID #: POSLS-union01
• Status: Recruiting
• Start date: August 18, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Fujian Medical University Union Hospital
• Contact: Maohui Chen
• Phone: +8618659181171
• Email: 757860733[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Stage I
• Quality of Life

Locations

Country	Name	City	State
China	Maohui Chen	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Change from baseline in pain scores on the Brief Pain Inventory and the McGill Pain Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.	12 months after surgery
Primary	Postoperative chronic cough	Number of participants with postoperative chronic cough as assessed by the Leicester Cough Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.	12 months after surgery
Primary	Quality of life after surgery	Change from baseline in quality of life scores on the European Organisation for Research and Treatment of Cancer 30 item Quality of Life Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.	12 months after surgery
Secondary	Anxiety status	Number of participants with anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS) and the Generalized Anxiety Disorder Screener (GAD-7) at postoperative weeks 1, 2, 4, 12, 26, and 52.	12 months after surgery
Secondary	Depression status	Number of participants with depression as assessed by the Hospital Anxiety and Depression Scale (HADS) and the Beck Depression Inventory (BDI) at postoperative weeks 1, 2, 4, 12, 26, and 52.	12 months after surgery