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

NCT ID: NCT03521986

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2023-10-30

Brief 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.

Detailed 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.

Conditions

Mediastinal Neoplasms; Thoracic Neoplasm; Thoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Subxiphoid uniportal VATS

Standard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader.

Group Type: EXPERIMENTAL

Subxiphoid uniportal VATS

Intervention Type: PROCEDURE

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

Standard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader.

Group Type: ACTIVE_COMPARATOR

Intercostal uniportal VATS

Intervention Type: PROCEDURE

The surgical procedures followed principles of pulmonary resections

Interventions

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

Intervention Type: PROCEDURE

Intercostal uniportal VATS

The surgical procedures followed principles of pulmonary resections

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lei Jiang

OTHER

Sponsor Role: lead

Responsible Party

Lei Jiang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

lei jiang, doctor

Role: CONTACT

jiangleiem@aliyun.com

86 13917912348

jian chen

Role: CONTACT

yufuchenjian@163.com

+8618817310041

Facility Contacts

jian chen

Role: primary

yufuchenjian@163.com

+8618817310041

Other Identifiers

leijiang2

Identifier Type: -

Identifier Source: org_study_id