Pain and Quality of Life After Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS
Primary Purpose
Mediastinal Neoplasms, Thoracic Neoplasm, Thoracic Surgery
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Subxiphoid uniportal VATS
Intercostal uniportal VATS
Sponsored by
About this trial
This is an interventional treatment trial for Mediastinal Neoplasms focused on measuring Mediastinal Neoplasms, Pain, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of anterial and middle mediastinal tumors ;
- Normal heart function, pulmonary function FEV1 %> 60% PaO2> 80 mmHg
- BMI<30
Exclusion Criteria:
- enlargement of lymph nodes was seen in the clinical CT readings.
- Preoperative chronic pain or chronic opioid analgesics
- Preoperative check for mental disorders such as hyper-anxiety
- History of previous thoracic surgery
- Patients with thoracic deformity (eg, funnel chest and chicken breast)
- Poor education can not understand postoperative follow-up requirements and assessment scale
Sites / Locations
- Shanghai Pulmonary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Subxiphoid uniportal VATS
Intercostal uniportal VATS
Arm Description
Standard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Standard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Outcomes
Primary Outcome Measures
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 ".
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03521986
Brief Title
Pain and Quality of Life After Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS
Official Title
Postoperative Pain and Quality of Life for Patients Undergoing Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Jiang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Neoplasms, Thoracic Neoplasm, Thoracic Surgery
Keywords
Mediastinal Neoplasms, Pain, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subxiphoid uniportal VATS
Arm Type
Experimental
Arm Description
Standard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Arm Title
Intercostal uniportal VATS
Arm Type
Active Comparator
Arm Description
Standard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Intervention Type
Procedure
Intervention Name(s)
Subxiphoid uniportal VATS
Intervention Description
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
Intervention Name(s)
Intercostal uniportal VATS
Intervention Description
The surgical procedures followed principles of pulmonary resections
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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 ".
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of anterial and middle mediastinal tumors ;
Normal heart function, pulmonary function FEV1 %> 60% PaO2> 80 mmHg
BMI<30
Exclusion Criteria:
enlargement of lymph nodes was seen in the clinical CT readings.
Preoperative chronic pain or chronic opioid analgesics
Preoperative check for mental disorders such as hyper-anxiety
History of previous thoracic surgery
Patients with thoracic deformity (eg, funnel chest and chicken breast)
Poor education can not understand postoperative follow-up requirements and assessment scale
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lei jiang, doctor
Phone
86 13917912348
Email
jiangleiem@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
jian chen
Phone
+8618817310041
Email
yufuchenjian@163.com
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jian chen
Phone
+8618817310041
Email
yufuchenjian@163.com
First Name & Middle Initial & Last Name & Degree
lei jiang, doctor
First Name & Middle Initial & Last Name & Degree
jian chen, doctor
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pain and Quality of Life After Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS
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