Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery

Trial Title: Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery

NCT ID: NCT06016881

Condition: Lung Cancer Stage I
Quality of Life

Conditions: Keywords:
lung cancer
Surgery
Quality of Life

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Detailed 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.

Criteria for eligibility:

Study pop:
The patient underwent a single-port thoracoscopic lung resection and had postoperative pathologic confirmation of stage I lung cancer or a benign lesion.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Maohui Chen

Address:
City: Fuzhou
Zip: 350100
Country: China

Status: Recruiting

Contact:
Last name: Maohui Chen

Phone: 18659181171
Email: 757860733@qq.com

Start date: August 18, 2023

Completion date: December 2024

Lead sponsor:
Agency: Fujian Medical University Union Hospital
Agency class: Other

Source: Fujian Medical University Union Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06016881