An interventional study of multi-port VATS and single-port VATS in Video-Assisted Thoracic Surgery, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy. The specific aims of this project are: to clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery: (1) multiple-port VATS; (2) single-port VATS
Video-assisted thoracoscopic surgery (VATS) was first reported in the early 1990s. Since then, the safety and efficacy of thoracoscopy for diagnosing and treating pleural, pulmonary, and mediastinal disease has been demonstrated with similar oncological results, which were confirmed by multiple clinical studies. Although VATS for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy, unfortunately chronic thoracic wound discomfort and postoperative neuralgia were found in a significant portion of patients .
Recently, a minimally invasive approach that is different from the conventional multiport thoracoscopic technique is gradually becoming of great interest in the diagnosis and treatment of thoracic surgical disease. Single-port VATS is one of the most promising emerging surgical techniques which allows the surgeon to perform a majority of thoracic surgeries and with similar perioperative outcomes that are comparable with the conventional multiport technique. However, a very limited number of clinical studies have demonstrated the advantages of single port VATS in postoperative pain reduction, when comparing to the traditional multiport thoracoscopic approach.
To clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery, investigators aim to compare the perioperative physiological changes, immunological responses, and postoperative pain between standard (multi-port) transthoracic thoracoscopic and single-port transthoracic thoracoscopic surgery for thoracic disease.
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's enrollment of 63 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.
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Exclusion Criteria:
Multi-port VATS is an operative method
Procedure: multi-port VATS
Single-port VATS is an operative method
Procedure: single-port VATS
Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.
Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.
Pain score
Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale
Time frame: beginning at 3 hours after surgery until 5 days
Complication
Yes/No
Time frame: beginning at 3 hours after surgery until 30 days
Mean arterial pressure
MAP; mmHg
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Heart rate
HR; beats per min \[bpm\]
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Cardiac index
CI; L/\[min·m2\]
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Systemic vascular resistance index
SVRI; \[dyn·s\]/\[cm-5·m2\]
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Global end-diastolic volume index
GEDVI; mL/m2
Time frame: beginning 20 min before the start of surgery until 20 min after the surgery.
Leukocyte subset analysis
10\^3/ul
Time frame: preoperation till 5 days after surgery
Intracellular oxidative activity of neutrophils
ratio compared with preoperation
Time frame: preoperation till 5 days after surgery
Inducible nitric oxide synthase expression in monocytes
Arbitrary intensity
Time frame: preoperation till 5 days after surgery
Interleukin-6
pg/ml
Time frame: preoperation till 5 days after surgery
C-reactive protein
ng/ml
Time frame: preoperation till 5 days after surgery
Plan to share: Yes — All collected IPD, all IPD that underlie results in a publication
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital