An Observational Study on the Quality of Life After Precise Lung Resection Through the Periareolar Incision

Surgical Incision Clinical Trial

Official title:

A Prospective Observational Study on the Quality of Life Post Minimally Invasive Thoracoscopic Precise Pneumonectomy Through the Periareolar Incision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202053
• Other study ID #: Union-99
• Status: Recruiting
• Start date: September 28, 2023
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Fujian Medical University Union Hospital
• Contact: Bin Zheng, MD
• Phone: 15959002753
• Email: Lacustrian[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

With the rapid development of video-assisted thoracoscopic technology, minimally invasive surgery has become the mainstream surgical approach and is widely known to the public. In addition to the pursuit of successful resection, patients seek an improvement in quality of life after surgery, which poses a challenge to surgeons. The surgical quality of uniportal video-assisted thoracoscopic surgery (VATS) is excellent. It has been shown to be superior to conventional VATS in many studies, especially with respect to the length of hospital stay and severity of pain/paresthesia. The rapid increase in the number of patients undergoing uniportal thoracoscopic surgery has led to the gradual widespread use of this technique. Therefore, how to further innovate this technology has become a direction of further research for surgeons. Here, we describe a rare uniportal thoracoscopic procedure through the perirareolar incision that has certain advantages over other uniportal thoracoscopic procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Be aged 18 years or above; 2. Histological examination confirmed NSCLC;3. Patients undergoing thoracic surgery who met the indication of thoracoscopic surgery; 4. Preoperative assessment of early stage lung cancer without evidence of advanced disease;5. No history of chemotherapy, immunotherapy or radiotherapy; 6. Society of Anesthesiologists (ASA) ?-?; 7. Volunteer for treatment and sign informed consent.

Exclusion Criteria:

• 1. Prior pulmonary resection or preoperative chemotherapy and/or radiotherapy; 2. There is a risk of thoracotomy or incision change during the operation, and the operation procedure may be complicated, with a large surgical scope (such as the left upper lobe, the whole lung, the right upper middle lung, etc.); 3. Preoperative assessment of poor lung function, unable to tolerate surgery; 4. Combined with other cancers or other terminal diseases; 5. Preoperative pulmonary infection or uncontrolled acute pulmonary disease or acute onset of chronic obstructive pulmonary disease; 6. Patients with severe hypertension (resting systolic/diastolic blood pressure over 180/100 mmHg), intracranial space occupation or intracranial hypertension; 7. Recent brain injury, cerebral infarction, cerebral hemorrhage; People with severe organ dysfunction; Hyperthyroidism; 8. History of angina pectoris, myocardial infarction or heart failure; 9. Thoracoscopic resection of mediastinum, pleura and other non-pulmonary masses; 10. Patients with central nervous system disease; Mental or nervous system disease, cognitive or language dysfunction, unable to cooperate with the completion of the interview; 11. Previous history of chest and back surgery or abnormal surgical anesthesia recovery history.

Related Conditions & MeSH terms

• Minimally Invasive Surgery
• Surgical Incision
• Surgical Wound

Intervention

Procedure:
• Type of surgical incision
The experimental group (patients received periareolar incision): An arc-shaped incision was made on the lateral side of the patient's affected areola. The subcutaneous tissue was then dissociated between the lateral mammary gland and the skin to the level of the fourth intercostal space in front of the midaxillary line. The fatty tissue behind the breast was separated horizontally to expose the serratus anterior muscle, and an intercostal incision was made. The skin was pulled back throughout the procedure to expose a better surgical field and avoid damage to the mammary gland. The control group (patients underwent an axillary incision): For patients in the control group, an incision was made into the fourth intercostal space in the midline of the axilla, where subcutaneous tissue was separated and entered the chest.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	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	The visual analogue scale was used to evaluate the degree of postoperative pain	1 month after the operation
Primary	Aesthetic satisfaction of incision	The cosmetic satisfaction of the patients with the incision was evaluated by the cosmetic rating scale during the postoperative follow-up	1 month after the operation
Secondary	Postoperative complications	Patients were followed up after surgery for complications	1 month after the operation