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Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

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ClinicalTrials.gov Identifier: NCT01397045
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital

Brief Summary:
Aim of this prospective randomized study is to assess the safety and efficacy of video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy (group A) during diagnostic process for pulmonary nodules.

Condition or disease Intervention/treatment Phase
Multiple Pulmonary Nodules Other: VATS Procedure: Mini thoracotomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Study Start Date : July 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Active Comparator: Video-assisted lung segmentectomy
Patients undergoing VATS segmentectomy
Other: VATS
Video-assisted lung segmentectomy

Mini thoracotomy
Patients undergoing lung segmentectomy through a mini thoracotomy
Procedure: Mini thoracotomy
Mini muscle sparing thoracotomy for lung segmentectomy




Primary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: Participants will be followed till home discharge, an average of 2 weeks ]

Secondary Outcome Measures :
  1. postoperative morbidity [ Time Frame: Participants will be followed till home discharge, an average of 2 weeks ]


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with undiagnosed multiple pulmonary nodules

Exclusion Criteria:

  • Centrally located lesions
  • previous thoracotomy
  • extensive lung consolidation, and inability to achieve one lung ventilation

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): NCT01397045


Locations
Greece
Thoracic Surgery Department, Theagenio Cancer Hospital
Thessaloniki, Greece, 54007
Sponsors and Collaborators
Theagenio Cancer Hospital

Responsible Party: Nikolaos Barbetakis, Head of Thoracic Surgery Department, Theagenio Cancer Hospital
ClinicalTrials.gov Identifier: NCT01397045     History of Changes
Other Study ID Numbers: Theagenio Thoracic Surgery 1
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Nikolaos Barbetakis, Theagenio Cancer Hospital:
Lung
Nodule
Rehabilitation
VATS
Thoracotomy

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases