Multiple Pulmonary NodulesNCT01397045
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy
A study testing VATS and Mini thoracotomy in people with Multiple Pulmonary Nodules, run by Theagenio Cancer Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Multiple Pulmonary Nodules
- What is being tested?
- VATS and Mini thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with undiagnosed multiple pulmonary nodules
Who cannot join
- Centrally located lesions
- previous thoracotomy
- extensive lung consolidation, and inability to achieve one lung ventilation
Trial locations and contacts
1 site in 1 country.
Greece1 site
Thoracic Surgery Department, Theagenio Cancer Hospital
Thessaloniki, 54007
About this study
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.
- Conditions
- Multiple Pulmonary Nodules
- Being tested
- VATS, Mini thoracotomy
- Keywords
- Lung, Nodule, Rehabilitation, VATS, Thoracotomy
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATSOther
Video-assisted lung segmentectomy
Mini thoracotomyProcedure or surgery
Mini muscle sparing thoracotomy for lung segmentectomy
| Study group | Role | What they receive |
|---|---|---|
| Video-assisted lung segmentectomy | Active comparator | Patients undergoing VATS segmentectomy Receives: Other: VATS |
| Mini thoracotomy | Other | Patients undergoing lung segmentectomy through a mini thoracotomy Receives: Procedure: Mini thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Measured: Participants will be followed till home discharge, an average of 2 weeks
Secondary outcomes (1)
postoperative morbidity
Measured: Participants will be followed till home discharge, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theagenio Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nikolaos Barbetakis, Theagenio Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397045
- Sponsor's protocol ID
- Theagenio Thoracic Surgery 1
- Status last verified
- Mar 2014
- First submitted
- 14 Jul 2011
- Last updated
- 28 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy
- ClinicalTrials.gov ID
- NCT01397045
- Acronym / sponsor ID
- Theagenio Thoracic Surgery 1
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- Lung, Nodule, Rehabilitation, VATS, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Theagenio Cancer HospitalOther government
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-assisted lung segmentectomy | Active comparator | Other: VATSPatients undergoing VATS segmentectomy |
| Mini thoracotomy | Other | Procedure: Mini thoracotomyPatients undergoing lung segmentectomy through a mini thoracotomy |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with undiagnosed multiple pulmonary nodules
Key exclusion criteria (3 listed)
- Centrally located lesions
- previous thoracotomy
- extensive lung consolidation, and inability to achieve one lung ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATSVideo-assisted lung segmentectomy | Other | Video-assisted lung segmentectomy |
| Mini thoracotomyMini muscle sparing thoracotomy for lung segmentectomy | Procedure or surgery | Mini thoracotomy |
Primary outcome
Duration of hospital stay
Time frame: Participants will be followed till home discharge, an average of 2 weeks
1 secondary outcome
postoperative morbidity
Time frame: Participants will be followed till home discharge, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VATS and Mini thoracotomy in people with Multiple Pulmonary Nodules, run by Theagenio Cancer Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: Participants will be followed till home discharge, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014.