Hemodynamic and Inflammatory Responses in Thoracic Surgery

January 19, 2020 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Video-Assisted Thoracic Surgery

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Taiwan
- - Taoyuan, Taiwan, 333
    - Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: multi-port VATS Multi-port VATS is an operative method	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.
Other: single-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score Time Frame: beginning at 3 hours after surgery until 5 days	Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale	beginning at 3 hours after surgery until 5 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

Principal Investigator: Yun-Hen Liu, Chang Gung Memorial Hospital
Principal Investigator: Hung-Pin Liu, Chang Gung Memorial Hospital
Principal Investigator: Yi-Cheng Wu, Chang Gung Memorial Hospital
Principal Investigator: Ming-Ju Hsieh, Chang Gung Memorial Hospital
Principal Investigator: Wei-Hsun Chen, Chang Gung Memorial Hospital
Principal Investigator: Yen Chu, Chang Gung Memorial Hospital
Principal Investigator: Chien-Ying Liu, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Thoracoscopic surgery

Additional Relevant MeSH Terms

Other Study ID Numbers

CGMH-IRB-104-7159A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Hemodynamic and Inflammatory Responses in Thoracic Surgery