Fast Track Rehabilitation Following Video-assisted Lung S... | NCT01397045

Studies
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

NCT01397045

Sponsor

Theagenio Cancer Hospital

Status

Completed

Last Update Posted

Mar 28, 2014Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Multiple Pulmonary Nodules

Interventions

VATS
Mini thoracotomy

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 18, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2014

Last Update Posted Date

Mar 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikolaos Barbetakis, Head of Thoracic Surgery Department, Theagenio Cancer HospitalPrincipal Investigator

Lead Sponsor

Theagenio Cancer HospitalOTHER_GOV

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VATS	Other	Video-assisted lung segmentectomy	Video-assisted lung segmentectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thoracic Surgery Department, Theagenio Cancer Hospital		Thessaloniki		54007	Greece

Condition Browse Module

MeSH Terms

ID	Term
D055613	Multiple Pulmonary Nodules

Ancestor Terms

ID	Term
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020775	Thoracic Surgery, Video-Assisted

Ancestor Terms

ID	Term
D013906	Thoracoscopy
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided