Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

• Sponsor: Theagenio Cancer Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01397045
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Pulmonary Nodules	Other: VATS; Procedure: Mini thoracotomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of hospital stay [Participants will be followed till home discharge, an average of 2 weeks]

Secondary Outcome Measures

1. postoperative morbidity [Participants will be followed till home discharge, an average of 2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Thoracic Surgery Department, Theagenio Cancer Hospital	Thessaloniki		Greece	54007

Sponsors and Collaborators

• Theagenio Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nikolaos Barbetakis, Head of Thoracic Surgery Department, Theagenio Cancer Hospital
• ClinicalTrials.gov Identifier: NCT01397045
• Other Study ID Numbers: Theagenio Thoracic Surgery 1
• First Posted: Jul 19, 2011
• Last Update Posted: Mar 28, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Nikolaos Barbetakis, Head of Thoracic Surgery Department, Theagenio Cancer Hospital: Lung; Nodule; Rehabilitation; VATS; Thoracotomy
• Additional relevant MeSH terms: Multiple Pulmonary Nodules

Study Results

No Results Posted as of Mar 28, 2014