Pain and Quality of Life After Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS
Postoperative Pain and Quality of Life for Patients Undergoing Mediastinal Tumor Resection by Subxiphoid and Intercostal VATS：A Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2018
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2018
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedMay 11, 2022
May 1, 2022
5.6 years
April 30, 2018
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of life
6 months
Study Arms (2)
Subxiphoid uniportal VATS
EXPERIMENTALStandard Subxiphoid single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Intercostal uniportal VATS
ACTIVE COMPARATORStandard Intercostal single-port video assisted mediastinal thymectomy, no use of rib-spreader.
Interventions
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
The surgical procedures followed principles of pulmonary resections
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of anterial and middle mediastinal tumors ;
- Normal heart function, pulmonary function FEV1 %\> 60% PaO2\> 80 mmHg
- BMI\<30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Jianglead
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, 200020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 11, 2018
Study Start
April 4, 2018
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share