Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery
NCT ID: NCT06016881
Last Updated: 2023-11-18
Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2023-08-18
2024-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Responsible Party
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Principal Investigators
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Maohui Chen
Role: STUDY_CHAIR
Fujian Medical University Union Hospital
Locations
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Maohui Chen
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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POSLS-union01
Identifier Type: -
Identifier Source: org_study_id
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