Pain and Quality of Life After Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS

Thoracic Surgery Clinical Trial

Official title:

Postoperative Pain and Quality of Life for Patients Undergoing Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS：A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521986
• Other study ID #: leijiang2
• Status: Recruiting
• Phase: Phase 3
• Start date: April 4, 2018
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: lei jiang, doctor
• Phone: 86 13917912348
• Email: jiangleiem[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. (1) The surgical field is fully exposed. (2) damage to intercostal nerves can be avoided.(3) Operation time, intraoperative blood loss, postoperative Extubation time is similar to VATS. But there is still lack of evidence.

In this study, 50 patients undergoing subxiphoid uniportal VATS and 50 patients undergoing intercostal uniportal VATS were included to evaluate the post-operative pain and quality of life after surgery.

Description:

The types of tumors in the medial mediastinal area were different. Thymoma, germ cell tumors, ectopic parathyroid tumors, and lymphoid tumors were in the anterior mediastinum. Bronchial cysts, pericardial cysts, and lymphomas were in the middle mediastinum. The principles of treatment for mediastinal tumor surgery must be both safe and radical. Radical resection is the dominant position in the treatment of mediastinal tumors, including traditional open surgery and thoracoscopic assisted minimally invasive surgery. At present, minimally invasive surgery for mediastinal tumor includes video-assisted thoracoscopic surgery via subxiphoid approach, left or right intercostal approach, trans-cervical approach and "Da Vinci" robotic system. Compared with conventional sternotomy, thoracoscopic assisted minimally invasive mediastinal tumor resection has clearer, multi-angle surgical vision, less trauma, less intraoperative blood loss, early postoperative extubation, and short postoperative hospital stay, postoperative recovery faster, less pain, fewer complications and meet the beauty needs and so on. Thoracoscopic assisted mediastinal thymectomy is currently one of the most commonly used surgical methods, but there are some deficiencies.

Minimally invasive surgery through the subxiphoid approach can achieve a good surgical field of vision. Compared with the traditional transcostal VATS medial mediastinal tumor resection, the subxiphoid thoracoscopic surgery had obvious advantages: (1) The surgical field is fully exposed. For patients with myasthenia gravis, it is particularly necessary to clean bilateral mediastinal adipose tissue; (2) Without intercostal surgery, damage to intercostal nerves can be avoided, postoperative pain can be reduced, and quality of life can be improved; (3) Operation time, intraoperative blood loss, postoperative Extubation time is similar to VATS. Disadvantages are as follows: (1) If there is a large hemorrhage during surgery, an emergency transfer to open the chest is required. The injury is greater and the operation is more troublesome; (2) Anterior septal space is Smaller, surgical instruments are more likely to interfere with each other. But there is still lack of evidence to prove which is better.

In this study, 100 patients with anterial and middle mediastinal tumors were selected as study subjects. 50 patients undergoing subxiphoid uniportal VATS were included in the observation group, and 50 patients undergoing intercostal uniportal VATS were included in the control group. The operation time, incision length, intraoperative blood loss, postoperative drainage time, postoperative drainage, hospitalization and hospitalization costs of the 2 groups would be observed. The clinical efficacy and incidence of complications were compared between the 2 groups. After six months of follow-up, postoperative pain and postoperative quality of life were observed in the 2 groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of anterial and middle mediastinal tumors ;

2. Normal heart function, pulmonary function FEV1 %> 60% PaO2> 80 mmHg

3. BMI<30

Exclusion Criteria:

1. enlargement of lymph nodes was seen in the clinical CT readings.

2. Preoperative chronic pain or chronic opioid analgesics

3. Preoperative check for mental disorders such as hyper-anxiety

4. History of previous thoracic surgery

5. Patients with thoracic deformity (eg, funnel chest and chicken breast)

6. Poor education can not understand postoperative follow-up requirements and assessment scale

Related Conditions & MeSH terms

• Mediastinal Neoplasms
• Neoplasms
• Thoracic Neoplasm
• Thoracic Neoplasms
• Thoracic Surgery

Intervention

Procedure:
• Subxiphoid uniportal VATS
Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections
• Intercostal uniportal VATS
The surgical procedures followed principles of pulmonary resections

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Lei Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".	6 months
Secondary	Quality of life	the EuroQol 5 Dimensions (EQ5D) and European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30) are used. EQ5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state. QLQ-C30 is a 30-item questionnaire, from which six functional domains of quality of life (physical function, emotional function, cognitive function, social function, and role function), and nine symptom domains (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite, constipation, diarrhoea, and financial difficulties) can be extracted, as well as an overall score.	6 months