PneumothoraxNCT01192217
Video-assisted Thoracic Surgery (VATS) Versus Axillary Mini-thoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax
A study testing Modified thoracoscopic technique and Axillary mini-thoracotomy in people with Pneumothorax, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Modified thoracoscopic technique and Axillary mini-thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2006to Feb 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ipsilateral recurrent spontaneous pneumothorax
- first episode of contralateral pneumothorax
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Greece1 site
AHEPA University Hospital Department of Cardiothoracic Surgery
Thessaloniki, 546 36
About this study
Official title: A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.
The investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution.
The main objective of the study was to investigate possible differences regarding short- and long-term clinical outcome between the two different techniques.
- Conditions
- Pneumothorax
- Being tested
- Modified thoracoscopic technique, Axillary mini-thoracotomy
- Keywords
- video-assisted thoracic surgery, axillary mini-thoracotomy, bullectomy
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified thoracoscopic techniqueProcedure or surgery
Also called VATS
Two-port thoracoscopic technique
Axillary mini-thoracotomyProcedure or surgery
Also called Thoracotomy
Axillary mini-thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| VATS group | Active comparator | Not described Receives: Procedure: Modified thoracoscopic technique |
| Mini-thoracotomy group | Active comparator | Not described Receives: Procedure: Axillary mini-thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumothorax recurrence rate
Recurrence rate
Postoperative complication rate
Postoperative complications
Patient satisfaction with treatment
Secondary outcomes (5)
Duration of one-lung ventilation
Total operative time
Duration of chest tube drainage
Length of postoperative hospital stay
Incidence of chronic pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJan 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christos Papakonstantinou, Professor, Study chair, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192217
- Sponsor's protocol ID
- AHEPACTS-01
- Status last verified
- Jan 2009
- First submitted
- 27 Aug 2010
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.
- ClinicalTrials.gov ID
- NCT01192217
- Acronym / sponsor ID
- AHEPACTS-01
- Conditions
- Pneumothorax
- Keywords
- video-assisted thoracic surgery, axillary mini-thoracotomy, bullectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 1 Sep 2010 (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.
The investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution.
The main objective of the study was to investigate possible differences regarding short- and long-term clinical outcome between the two different techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS group | Active comparator | Procedure: Modified thoracoscopic technique |
| Mini-thoracotomy group | Active comparator | Procedure: Axillary mini-thoracotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ipsilateral recurrent spontaneous pneumothorax
- first episode of contralateral pneumothorax
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Modified thoracoscopic techniqueAlso: VATSTwo-port thoracoscopic technique | Procedure or surgery | VATS group |
| Axillary mini-thoracotomyAlso: ThoracotomyAxillary mini-thoracotomy | Procedure or surgery | Mini-thoracotomy group |
Primary outcome
pneumothorax recurrence rate
Recurrence rate
Postoperative complication rate
Postoperative complications
Patient satisfaction with treatment
5 secondary outcomes
Duration of one-lung ventilation
Total operative time
Duration of chest tube drainage
Length of postoperative hospital stay
Incidence of chronic pain
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 1 Sep 2010.
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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.
Christos Papakonstantinou, Professor study chair
AHEPA University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified thoracoscopic technique and Axillary mini-thoracotomy in people with Pneumothorax, run by AHEPA University 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 2 inclusion and 1 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 1 Sep 2010. 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?
pneumothorax recurrence rate. The study lists 3 primary outcomes in all. 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 1 Sep 2010.