Hemodynamic and Inflammatory Responses in Thoracic Surgery

Not Applicable

Completed

• Conditions: Video-Assisted Thoracic Surgery
• Interventions: Procedure: multi-port VATS; Procedure: single-port VATS

• Registration Number: NCT02647775
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-12-28
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Primary Completion: 2018-01
• Study Completion: 2018-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multi-port VATS	multi-port VATS	Multi-port VATS is an operative method
single-port VATS	single-port VATS	Single-port VATS is an operative method

Primary Outcome Measures

Name	Time	Method
Pain score	beginning at 3 hours after surgery until 5 days	Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale

Secondary Outcome Measures

Name	Time	Method
Interleukin-6	preoperation till 5 days after surgery	pg/ml
Mean arterial pressure	beginning 20 min before the start of surgery until 20 min after the surgery.	MAP; mmHg
Inducible nitric oxide synthase expression in monocytes	preoperation till 5 days after surgery	Arbitrary intensity
C-reactive protein	preoperation till 5 days after surgery	ng/ml
Cardiac index	beginning 20 min before the start of surgery until 20 min after the surgery.	CI; L/\[min·m2\]
Complication	beginning at 3 hours after surgery until 30 days	Yes/No
Systemic vascular resistance index	beginning 20 min before the start of surgery until 20 min after the surgery.	SVRI; \[dyn·s\]/\[cm-5·m2\]
Global end-diastolic volume index	beginning 20 min before the start of surgery until 20 min after the surgery.	GEDVI; mL/m2
Intracellular oxidative activity of neutrophils	preoperation till 5 days after surgery	ratio compared with preoperation
Heart rate	beginning 20 min before the start of surgery until 20 min after the surgery.	HR; beats per min \[bpm\]
Leukocyte subset analysis	preoperation till 5 days after surgery	10\^3/ul

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan