NCT01397045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

2.7 years

First QC Date

July 14, 2011

Last Update Submit

March 26, 2014

Conditions

Multiple Pulmonary Nodules

Keywords

LungNoduleRehabilitationVATSThoracotomy

Outcome Measures

Primary Outcomes (1)

  • Duration of hospital stay

    Participants will be followed till home discharge, an average of 2 weeks

Secondary Outcomes (1)

  • postoperative morbidity

    Participants will be followed till home discharge, an average of 2 weeks

Study Arms (2)

Video-assisted lung segmentectomy

ACTIVE COMPARATOR

Patients undergoing VATS segmentectomy

Other: VATS

Mini thoracotomy

OTHER

Patients undergoing lung segmentectomy through a mini thoracotomy

Procedure: Mini thoracotomy

Interventions

VATSOTHER

Video-assisted lung segmentectomy

Video-assisted lung segmentectomy
Mini thoracotomyPROCEDURE

Mini muscle sparing thoracotomy for lung segmentectomy

Mini thoracotomy

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with undiagnosed multiple pulmonary nodules

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoracic Surgery Department, Theagenio Cancer Hospital

Thessaloniki, 54007, Greece

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Thoracic Surgery Department

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

GR(1)