PneumothoraxNCT05407974
Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax
A study testing pleurectomy in people with Pneumothorax, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pneumothorax refers to air in the pleural cavity (i.e. interspersed between the lung and the chest wall).1 Primary spontaneous pneumothorax (PSP) mostly occurs in healthy individuals without an apparent cause, probably due to the rupture of subpleural blebs located mostly on the apex of the lung or the apical segment… Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumothorax
- What is being tested?
- pleurectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2021to 1 May 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- - Patients presented with spontaneous pneumothorax; primary or secondary.
- Age: all age groups are included
- Approach: Video assisted thoracoscopic surgery
Who cannot join
- - Refusal of procedure or participation in the study.
- Patients with acquired pneumothorax (eg. Traumatic)
- Patients with history of previous thoracic surgery on the same side of chest.
- Approach: any open thoracotomy approach or switching from VATS to open thoracotomy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University
Cairo, 11511
Abdelfatah E Abugabal, MSC, MBBCH, 01098064416, abdelfatah_abugabal@hotmail.com
Ahmed M Mostafa, +201098064416, abdelfatah_abugabal@hotmail.com
About this study
Pneumothorax refers to air in the pleural cavity (i.e. interspersed between the lung and the chest wall).1 Primary spontaneous pneumothorax (PSP) mostly occurs in healthy individuals without an apparent cause, probably due to the rupture of subpleural blebs located mostly on the apex of the lung or the apical segment of the lower lobe. Compared to PSP, a secondary spontaneous pneumothorax (SSP) occurs in the setting of underlying pulmonary disease, like COPD.2 Surgical treatment involves resection of apical bleb disease and pleurodesis which could be chemical or mechanical. Mechanical pleurodesis accomplished either via pleurectomy or pleural abrasion.3 In this study, we aim to compare the efficiency and recurrence risk of pleural abrasion versus pleurectomy in patients with Spontaneous pneumothorax.
Read the detailed description
Pneumothorax is a relatively common clinical problem which can occur in individuals of any age. Irrespective of aetiology (primary, or secondary to lung disorders or injury), immediate management depends on the extent of cardiorespiratory impairment, degree of symptoms and size of pneumothorax. 4 The presentation of a pneumothorax varies between minimal pleuritic chest discomfort and breathlessness to a life threatening medical emergency with cardiorespiratory collapse requiring immediate intervention.5-7 Typical signs include reduced breath sounds, reduced ipsilateral chest expansion and hyper resonant percussion note. Mediastinal shift away from the affected side, tachycardia, tachypnea and hypotension occur in Tension pneumothorax. 8 Pneumothorax can be categorized as spontaneous which maybe primary or secondary and traumatic according to aetiology. Occasionally, individuals may develop a concomitant haemothorax due to bleeding caused by shearing of adjacent subpleural vessels when the lung collapses.4 A primary spontaneous pneumothorax (PSP) is a condition that occurs predominantly in young and thin male individuals who do not have any history of underlying lung disease. Although it is mostly attributed to the rupture of a subpleural bleb or bulla, the exact cause of PSP is still unknown.1 Moreover, current cigarette smoking greatly increases the risk of developing PSP by as much as nine times, with evidence of a dose-response relationship.9 Secondary spontaneous pneumothorax (SSP) frequently occurs in association with primary diseases, such as chronic obstructive pulmonary disease (COPD), interstitial pneumonia (IP), and pulmonary fibrosis disease (PFD). 10 Treatment of spontaneous pneumothorax depends on the patient's condition and can range from conservative treatment, drainage, and pleurodesis, to surgical treatment.10 Surgical treatment is based on resection of bullous lesions causing air leakage and techniques to prevent recurrence. Surgical treatment without additional pleurodesis may increase the risk of recurrence, Various pleurodesis techniques such as chemical pleurodesis or mechanical pleurodesis via pleural abrasion or pleurectomy are used to reduce the recurrence rate.1
- Conditions
- Pneumothorax
- Being tested
- pleurectomy
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleurectomyProcedure or surgery
Also called bullectomy
All patients will undergo resection of apical blebs with simultaneous pleurectomy or pleural abrasion.
Chest tube will be inserted in the pleural cavity and maybe connected on low-grade suction for first 24 h according to type of pneumothorax \& surgeons' preference, after which the suction is disconnected.
Post Operatively both groups will be compared regarding the postoperative drainage amount, persistence of air leak (chest tube removal time), length of hospital stay, mortality and risk of recurrence.
Follow up Chest x-ray will be done immediate postoperatively, then each patient will be followed up after 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pleural abrasion Group | Experimental | Mechanical pleural abrasion will be performed by rubbing the parietal pleura with gauze or a cleaning pad. Receives: Procedure: pleurectomy |
| pleurectomy group | Experimental | Pleurectomy will be performed by a small piece of gauze on grasper. The aim of pleurectomy is to remove the parietal pleural especially above the areas with blebs or bullae. Receives: Procedure: pleurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Recurrence
Incidence of recurrence of pneumothorax is measured by clinical examination and chest x ray done at 3 and at 6 month postoperative
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start3 Oct 2021
- Primary completion1 Feb 2023
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdelfatah E Abugabal, Principal investigator, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407974
- Sponsor's protocol ID
- Pleurectomy Versus abrasion
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ocakcioglu I, Kupeli M. Surgical Treatment of Spontaneous Pneumothorax: Pleural Abrasion or Pleurectomy? Surg Laparosc Endosc Percutan Tech. 2019 Feb;29(1):58-63. doi: 10.1097/SLE.0000000000000595.
PubMed 30499890Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii39-52. doi: 10.1136/thorax.58.suppl_2.ii39. No abstract available.
PubMed 12728149Joharifard S, Coakley BA, Butterworth SA. Pleurectomy versus pleural abrasion for primary spontaneous pneumothorax in children. J Pediatr Surg. 2017 May;52(5):680-683. doi: 10.1016/j.jpedsurg.2017.01.012. Epub 2017 Jan 27.
PubMed 28168984
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT05407974
- Acronym / sponsor ID
- Pleurectomy Versus abrasion
- Conditions
- Pneumothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 7 Jun 2022 (actual)
- 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.
Pneumothorax refers to air in the pleural cavity (i.e. interspersed between the lung and the chest wall).1 Primary spontaneous pneumothorax (PSP) mostly occurs in healthy individuals without an apparent cause, probably due to the rupture of subpleural blebs located mostly on the apex of the lung or the apical segment of the lower lobe. Compared to PSP, a secondary spontaneous pneumothorax (SSP) occurs in the setting of underlying pulmonary disease, like COPD.2 Surgical treatment involves resection of apical bleb disease and pleurodesis which could be chemical or mechanical. Mechanical pleurodesis accomplished either via pleurectomy or pleural abrasion.3 In this study, we aim to compare the efficiency and recurrence risk of pleural abrasion versus pleurectomy in patients with Spontaneous pneumothorax.
Detailed description
Pneumothorax is a relatively common clinical problem which can occur in individuals of any age. Irrespective of aetiology (primary, or secondary to lung disorders or injury), immediate management depends on the extent of cardiorespiratory impairment, degree of symptoms and size of pneumothorax. 4 The presentation of a pneumothorax varies between minimal pleuritic chest discomfort and breathlessness to a life threatening medical emergency with cardiorespiratory collapse requiring immediate intervention.5-7 Typical signs include reduced breath sounds, reduced ipsilateral chest expansion and hyper resonant percussion note. Mediastinal shift away from the affected side, tachycardia, tachypnea and hypotension occur in Tension pneumothorax. 8 Pneumothorax can be categorized as spontaneous which maybe primary or secondary and traumatic according to aetiology. Occasionally, individuals may develop a concomitant haemothorax due to bleeding caused by shearing of adjacent subpleural vessels when the lung collapses.4 A primary spontaneous pneumothorax (PSP) is a condition that occurs predominantly in young and thin male individuals who do not have any history of underlying lung disease. Although it is mostly attributed to the rupture of a subpleural bleb or bulla, the exact cause of PSP is still unknown.1 Moreover, current cigarette smoking greatly increases the risk of developing PSP by as much as nine times, with evidence of a dose-response relationship.9 Secondary spontaneous pneumothorax (SSP) frequently occurs in association with primary diseases, such as chronic obstructive pulmonary disease (COPD), interstitial pneumonia (IP), and pulmonary fibrosis disease (PFD). 10 Treatment of spontaneous pneumothorax depends on the patient's condition and can range from conservative treatment, drainage, and pleurodesis, to surgical treatment.10 Surgical treatment is based on resection of bullous lesions causing air leakage and techniques to prevent recurrence. Surgical treatment without additional pleurodesis may increase the risk of recurrence, Various pleurodesis techniques such as chemical pleurodesis or mechanical pleurodesis via pleural abrasion or pleurectomy are used to reduce the recurrence rate.1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleural abrasion Group | Experimental | Procedure: pleurectomyMechanical pleural abrasion will be performed by rubbing the parietal pleura with gauze or a cleaning pad. |
| pleurectomy group | Experimental | Procedure: pleurectomyPleurectomy will be performed by a small piece of gauze on grasper. The aim of pleurectomy is to remove the parietal pleural especially above the areas with blebs or bullae. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- - Patients presented with spontaneous pneumothorax; primary or secondary.
- Age: all age groups are included
- Approach: Video assisted thoracoscopic surgery
Key exclusion criteria (4 listed)
- - Refusal of procedure or participation in the study.
- Patients with acquired pneumothorax (eg. Traumatic)
- Patients with history of previous thoracic surgery on the same side of chest.
- Approach: any open thoracotomy approach or switching from VATS to open thoracotomy
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 |
|---|---|---|
| pleurectomyAlso: bullectomyAll patients will undergo resection of apical blebs with simultaneous pleurectomy or pleural abrasion. Chest tube will be inserted in the pleural cavity and maybe connected on low-grade suction for first 24 h according to type of pneumothorax \& surgeons' preference, after which the suction is disconnected. Post Operatively both groups will be compared regarding the postoperative drainage amount, persistence of air leak (chest tube removal time), length of hospital stay, mortality and risk of recurrence. Follow up Chest x-ray will be done immediate postoperatively, then each patient will be followed up after 6 months. | Procedure or surgery | Pleural abrasion Group, pleurectomy group |
Primary outcome
Incidence of Recurrence
Time frame: 6 months
Incidence of recurrence of pneumothorax is measured by clinical examination and chest x ray done at 3 and at 6 month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 30499890Ocakcioglu I, Kupeli M. Surgical Treatment of Spontaneous Pneumothorax: Pleural Abrasion or Pleurectomy? Surg Laparosc Endosc Percutan Tech. 2019 Feb;29(1):58-63. doi: 10.1097/SLE.0000000000000595.
- Background: PubMed 12728149Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii39-52. doi: 10.1136/thorax.58.suppl_2.ii39. No abstract available.
- Background: PubMed 28168984Joharifard S, Coakley BA, Butterworth SA. Pleurectomy versus pleural abrasion for primary spontaneous pneumothorax in children. J Pediatr Surg. 2017 May;52(5):680-683. doi: 10.1016/j.jpedsurg.2017.01.012. Epub 2017 Jan 27.
- Individual participant dataSharing planned: No
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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.
Abdelfatah E Abugabal principal investigator
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pleurectomy in people with Pneumothorax, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelfatah E Abugabal (+201098064416, abdelfatah_abugabal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407974, which also lists 3 linked publications.
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 24 Mar 2023.