Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Lung Cancer Stage I

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Maohui Chen; Phone Number: +8618659181171; Email: 757860733@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350100
      • Recruiting
      • Maohui Chen
      • Contact: Maohui Chen; Phone Number: 18659181171; Email: 757860733@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Study Chair: Maohui Chen, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Surgery; lung cancer
• Other Study ID Numbers: POSLS-union01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No