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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202053
Other study ID # Union-99
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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