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Hemodynamic and Inflammatory Responses in Thoracic Surgery

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Video-Assisted Thoracic Surgery

Treatments

Procedure: single-port VATS
Procedure: multi-port VATS

Study type

Interventional

Funder types

Other

Identifiers

NCT02647775
CGMH-IRB-104-7159A3

Details and patient eligibility

About

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

Full 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.

Enrollment

63 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

multi-port VATS
Other group
Description:
Multi-port VATS is an operative method
Treatment:
Procedure: multi-port VATS
single-port VATS
Other group
Description:
Single-port VATS is an operative method
Treatment:
Procedure: single-port VATS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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