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Trial record 11 of 14 for:    Recruiting, Not yet recruiting, Available Studies | "Thoracic Diseases"

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

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ClinicalTrials.gov Identifier: NCT03521986
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China

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.


Condition or disease Intervention/treatment Phase
Mediastinal Neoplasms Thoracic Neoplasm Thoracic Surgery Procedure: Subxiphoid uniportal VATS Procedure: Intercostal uniportal VATS Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain and Quality of Life for Patients Undergoing Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS:A Randomized Controlled Trial
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Subxiphoid uniportal VATS
Standard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader.
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

Active Comparator: Intercostal uniportal VATS
Standard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Procedure: Intercostal uniportal VATS
The surgical procedures followed principles of pulmonary resections




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 6 months ]
    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 :
  1. Quality of life [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521986


Contacts
Contact: lei jiang, doctor 86 13917912348 jiangleiem@aliyun.com
Contact: jian chen +8618817310041 yufuchenjian@163.com

Locations
China
Shanghai Pulmonary Hospital Recruiting
Shanghai, China, 200020
Contact: jian chen    +8618817310041    yufuchenjian@163.com   
Principal Investigator: lei jiang, doctor         
Sub-Investigator: jian chen, doctor         
Sponsors and Collaborators
Lei Jiang

Responsible Party: Lei Jiang, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03521986     History of Changes
Other Study ID Numbers: leijiang2
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China:
Mediastinal Neoplasms
Pain
Quality of life

Additional relevant MeSH terms:
Neoplasms
Thoracic Neoplasms
Mediastinal Neoplasms
Neoplasms by Site
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases