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The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy

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ClinicalTrials.gov Identifier: NCT03051438
Recruitment Status : Unknown
Verified May 2018 by Xueying Yang, Shengjing Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Xueying Yang, Shengjing Hospital

Study Description
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Brief Summary:
Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has emerged as a promising and exciting approach for minimally invasive thoracic surgery. However, nearly all reported uniportal VATS lobectomies have been performed via the intercostal route, and chest wall trauma has still occurred. Here,the investigators undertook novel uniportal VATS technique involving a subxiphoid route for pulmonary lobectomies to evaluate the feasibility and advantages.

Condition or disease Intervention/treatment Phase
Lobectomy Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery Procedure: Subxiphoid uniportal VATS Procedure: Three-port VATS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Feasibility and Advantages of Subxiphoid Uniportal Video-assisted Thoracoscopic Surgery in Pulmonary Lobectomy.A Retrospective Study
Actual Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018
Arms and Interventions
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Arm Intervention/treatment
Subxiphoid uniportal VATS
retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies
 Procedure: Subxiphoid uniportal VATS
Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi.
Three-port VATS
retrospectively analyzed and compared perioperative data for patients who underwent subxiphoid uniportal and traditional three-port VATS lobectomies
 Procedure: Three-port VATS
The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 17 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with lung cancer can be undertook the subxiphoid uniportal VATS or three-port VATS

Exclusion Criteria:

  • Contraindications in patients with lung cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051438


Locations
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China, Liaoning
Shengjing Hospital
Shenyang, Liaoning, China, 110004
Sponsors and Collaborators
Xueying Yang
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xueying Yang, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03051438    
Other Study ID Numbers: B451-1
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No