Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

March 26, 2014 updated by: Nikolaos Barbetakis, Theagenio Cancer Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54007
        • Thoracic Surgery Department, Theagenio Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Video-assisted lung segmentectomy
Patients undergoing VATS segmentectomy
Other: VATS
Video-assisted lung segmentectomy
Other: Mini thoracotomy
Patients undergoing lung segmentectomy through a mini thoracotomy
Procedure: Mini thoracotomy
Mini muscle sparing thoracotomy for lung segmentectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of hospital stay
Time Frame: Participants will be followed till home discharge, an average of 2 weeks
Participants will be followed till home discharge, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative morbidity
Time Frame: Participants will be followed till home discharge, an average of 2 weeks
Participants will be followed till home discharge, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theagenio Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Theagenio Thoracic Surgery 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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