Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01397045
First received: July 14, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Multiple Pulmonary Nodules
Other: VATS
Procedure: Mini thoracotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Theagenio Cancer Hospital:

Primary Outcome Measures:
  • Duration of hospital stay [ Time Frame: Participants will be followed till home discharge, an average of 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative morbidity [ Time Frame: Participants will be followed till home discharge, an average of 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397045

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

No publications provided

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
Study First Received: July 14, 2011
Last Updated: March 26, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014