Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery

NCT06016881 | Unknown

• 1 other identifier: POSLS-union01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer Stage I; Quality of Life

Keywords

lung cancer; Surgery; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Anxiety status

  12 months after surgery

• Depression status

  12 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Previous thoracic surgery
• Any type of chronic pain, requiring daily use of analgetics
• Any type of chronic cough that requires daily medication
• pregnant
• Breast feeding
• contraindications to NSAID
• Combination of other tumors requiring chemotherapy or radiotherapy

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Maohui Chen

Fuzhou, Fujian, 350100, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39097304 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maohui Chen

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Maohui Chen

CONTACT

+8618659181171; 757860733@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 30, 2023
• Study Start: August 18, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-08

Locations

CN (1)