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Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax

Primary Purpose

Pneumothorax

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pleurectomy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Patients presented with spontaneous pneumothorax; primary or secondary.
  • Age: all age groups are included
  • Approach: Video assisted thoracoscopic surgery

Exclusion Criteria:

  • - 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

Sites / Locations

  • Ainshams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pleural abrasion Group

pleurectomy group

Arm Description

Mechanical pleural abrasion will be performed by rubbing the parietal pleura with gauze or a cleaning pad.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
March 22, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05407974
Brief Title
Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax
Official Title
Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pleural abrasion Group
Arm Type
Experimental
Arm Description
Mechanical pleural abrasion will be performed by rubbing the parietal pleura with gauze or a cleaning pad.
Arm Title
pleurectomy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pleurectomy
Other Intervention Name(s)
bullectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Recurrence
Description
Incidence of recurrence of pneumothorax is measured by clinical examination and chest x ray done at 3 and at 6 month postoperative
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patients presented with spontaneous pneumothorax; primary or secondary. Age: all age groups are included Approach: Video assisted thoracoscopic surgery Exclusion Criteria: - 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelfatah E Abugabal
Phone
+201098064416
Email
abdelfatah_abugabal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelfatah E Abugabal
Organizational Affiliation
Ainshams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ainshams University
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelfatah E Abugabal, MSC, MBBCH
Phone
01098064416
Email
abdelfatah_abugabal@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed M Mostafa
Phone
+201098064416
Email
abdelfatah_abugabal@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30499890
Citation
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.
Results Reference
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PubMed Identifier
12728149
Citation
Henry 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.
Results Reference
background
PubMed Identifier
28168984
Citation
Joharifard 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.
Results Reference
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Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax

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