Hemodynamic and Inflammatory Responses in Thoracic Surgery

Video-Assisted Thoracic Surgery Clinical Trial

Official title:

Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647775
• Other study ID #: CGMH-IRB-104-7159A3
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patient with thoracic surgical diseases(lung cancer. mediastinal tumor. solitary pulmonary lesion. pneumothorax) who will be underwent video-assisted thoracic surgery

Exclusion Criteria:

• Unresectable mediastinal tumor

• Previous history of ipsilateral pulmonary resection

• Patients with complex cardiopulmonary dysfunction

• Unresectable pulmonary hilar tumor

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Video-Assisted Thoracic Surgery

Intervention

Procedure:
• multi-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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (33)

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Lu HY, Chu Y, Wu YC, Liu CY, Hsieh MJ, Chao YK, Wu CY, Yuan HC, Ko PJ, Liu YH, Liu HP. Hemodynamic and inflammatory responses following transumbilical and transthoracic lung wedge resection in a live canine model. Int J Surg. 2015 Apr;16(Pt A):116-122. doi: 10.1016/j.ijsu.2015.02.027. Epub 2015 Mar 11. — View Citation

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Natsume T, Kawahira H, Hayashi H, Nabeya Y, Akai T, Horibe D, Shuto K, Akutsu Y, Matsushita K, Nomura F, Matsubara H. Low peritoneal and systemic inflammatory response after laparoscopy-assisted gastrectomy compared to open gastrectomy. Hepatogastroenterology. 2011 Mar-Apr;58(106):659-62. — View Citation

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Ng CS, Wan S, Hui CW, Lee TW, Underwood MJ, Yim AP. Video-assisted thoracic surgery for early stage lung cancer - can short-term immunological advantages improve long-term survival? Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):308-12. Review. — View Citation

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Rocco G, Martin-Ucar A, Passera E. Uniportal VATS wedge pulmonary resections. Ann Thorac Surg. 2004 Feb;77(2):726-8. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale	beginning at 3 hours after surgery until 5 days
Secondary	Complication	Yes/No	beginning at 3 hours after surgery until 30 days
Secondary	Mean arterial pressure	MAP; mmHg	beginning 20 min before the start of surgery until 20 min after the surgery.
Secondary	Heart rate	HR; beats per min [bpm]	beginning 20 min before the start of surgery until 20 min after the surgery.
Secondary	Cardiac index	CI; L/[min·m2]	beginning 20 min before the start of surgery until 20 min after the surgery.
Secondary	Systemic vascular resistance index	SVRI; [dyn·s]/[cm-5·m2]	beginning 20 min before the start of surgery until 20 min after the surgery.
Secondary	Global end-diastolic volume index	GEDVI; mL/m2	beginning 20 min before the start of surgery until 20 min after the surgery.
Secondary	Leukocyte subset analysis	10^3/ul	preoperation till 5 days after surgery
Secondary	Intracellular oxidative activity of neutrophils	ratio compared with preoperation	preoperation till 5 days after surgery
Secondary	Inducible nitric oxide synthase expression in monocytes	Arbitrary intensity	preoperation till 5 days after surgery
Secondary	Interleukin-6	pg/ml	preoperation till 5 days after surgery
Secondary	C-reactive protein	ng/ml	preoperation till 5 days after surgery