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NCT01397045 Clinical Trial

Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

Multiple Pulmonary Nodules Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01397045
Other study ID # Theagenio Thoracic Surgery 1
Secondary ID
Status Completed
Phase N/A
First received July 14, 2011
Last updated March 26, 2014
Start date July 2011
Est. completion date March 2014

Study information
Verified date March 2014
Source Theagenio Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 80 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• VATS
Video-assisted lung segmentectomy
Procedure:
• Mini thoracotomy
Mini muscle sparing thoracotomy for lung segmentectomy

Locations
Country Name City State
Greece Thoracic Surgery Department, Theagenio Cancer Hospital Thessaloniki

Sponsors (1)
Lead Sponsor Collaborator
Theagenio Cancer Hospital

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of hospital stay Participants will be followed till home discharge, an average of 2 weeks Yes
Secondary postoperative morbidity Participants will be followed till home discharge, an average of 2 weeks Yes
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