Hemodynamic and Inflammatory Responses in Thoracic Surgery

NCT02647775 | Completed DMC

• 1 other identifier: CGMH-IRB-104-7159A3
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Video-Assisted Thoracic Surgery

Keywords

Thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Pain score

  Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale

  beginning at 3 hours after surgery until 5 days

Secondary Outcomes (11)

• Complication

  beginning at 3 hours after surgery until 30 days

• Mean arterial pressure

  beginning 20 min before the start of surgery until 20 min after the surgery.

• Heart rate

  beginning 20 min before the start of surgery until 20 min after the surgery.

• Cardiac index

  beginning 20 min before the start of surgery until 20 min after the surgery.

• Systemic vascular resistance index

  beginning 20 min before the start of surgery until 20 min after the surgery.

Study Arms (2)

multi-port VATS

OTHER

Multi-port VATS is an operative method

Procedure: multi-port VATS

single-port VATS

OTHER

Single-port VATS is an operative method

Procedure: single-port VATS

Interventions

multi-port VATS PROCEDURE

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.

multi-port VATS

single-port VATS PROCEDURE

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unresectable mediastinal tumor
• Previous history of ipsilateral pulmonary resection
• Patients with complex cardiopulmonary dysfunction
• Unresectable pulmonary hilar tumor

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (33)

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Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication

Locations

TW (1)