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Clinical Trials/NCT03943069
NCT03943069UnknownNot Applicable

Thoracoscopic Bullectomy Versus Thoracoscopic Bullectomy and Pleurodesis For Management of Primary Spontaneous Pneumothorax; A Prospective Multicenter Randomized Controlled Study

Imam Abdulrahman Bin Faisal University1 site in 1 country232 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
232
Locations
1
Primary Endpoint
Recurrence of pneumothorax

Study Overview

Brief Summary

The exact pathogenesis of PSP is controversial. A few theories has been proposed contributing to the pathogenesity of the PSP as emphysematous like changes (ELCs) which lead to the formation and rupture of the lung bullae or blebs; and increased pleural porosity which is an abnormality of the visceral pleura. The Video-Assisted Thoracoscopic Surgery with bullectomy only is an effective preventive method of PSP recurrence. Adding mechanical pleurodesis to bullectomy is still questionable in the literature. This prospective multicenter study will identify the rate of PSP recurrence after thoracoscopic bullectomy only versus thoracoscopic bullectomy with mechanical pleurodesis.

Detailed Description

Background The pneumothorax may be defined as presence of air in the pleural cavity which then leads to a decrease in lung expansion, and consequently lung collapse. The pneumothorax occurs due to air lodged at the pleural space either between the pleural cavity and the alveolar between the pleural cavity and the atmosphere; or the presence of organisms that produce gases (1).

The pneumothorax can be classified into spontaneous or traumatic. The spontaneous pneumothorax (SP) is either classified into primary SP that has no underlying lung disease; or secondary SP that occurs in underlying lung disease as Chronic Obstructive Pulmonary Diseases (COPDs), or in conjugation with menstrual period causing catamenial pneumothorax (1).

The exact pathogenesis of primary spontaneous pneumothorax (PSP) is controversial. The theories beyond the pathology of PSP has includes: emphysematous like changes (ELCs) which cause formation and rupture of the blebs or bullae; increased pleural porosity which is an abnormality of the visceral pleura seen under fluorescein lighting; and inflammation of the distal airways which lead to fibrotic change and compensatory emphysematous bulla (2). The development of the previous etiologies are linked to genetic predisposition, anatomical abnormalities, connective tissues abnormalities, body mass index under 18.5 kg/m2, decrease caloric intake, and apical ischemia(3).

In the literature there was a superiority in treatment of PSP with the Video-assisted thoracoscopic surgery (VATS) is in compare to thoracotomy, as it has less tissue damage, less postoperative pain, less hospitalization stay, better cosmetic outcome, and earlier return to normal daily life activities (4). The debate on the ideal preventive method of PSP recurrence using VATS spotlights on the main etiologies of the treatment of bleb and bullae by the bullectomy and the pleural abnormalities by pleurodesis(5).

VATS with bullectomy alone is an effective method of decreasing the chance of PSP recurrence, while additive of mechanical pleurodesis is questionable as different studies showed variable results(6-8). This multicenter randomized control trial study will compare the recurrence rate of PSP post thoracoscopic bullectomy alone in compare with thoracoscopic bullectomy in addition to mechanical pleurodesis.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 45 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Primary spontaneous pneumothorax
  • •Male or female
  • •Age 16-45

Exclusion Criteria

  • •Hemopneumothorax
  • •Previous thoracic surgical intervention
  • •Patient undergoing thoracotomy

Arms & Interventions

Patient with PSP

Experimental

Patient who will be admitted with primary spontaneous pneumothorax.

Intervention: Thoracoscopic bullectomy alone (Procedure)

Patient with PSP

Experimental

Patient who will be admitted with primary spontaneous pneumothorax.

Intervention: Thoracoscopic bullectomy with pleurodesis (Procedure)

Outcomes

Primary Outcomes

Recurrence of pneumothorax

Time Frame: 6 months

The evaluation of recurrence of primary spontaneous pneumothorax will be via the radiological studies (Chest x-ray) that will be performed during the follow-up visits in 1 week, 1 month, 3 months and 6 months after hospital discharge. Moreover, symptoms such as respiratory distress and ipsilateral chest pain during the follow up period will be considered as a recurrence of pneumothorax which requires further evaluation and confirmation by radiological studies. The number of recurrences during the follow up period will be compared between the two groups for any statistical difference.

Secondary Outcomes

  • Drainage and air leak(1 week)
  • Postoperative Pain(1 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hatem Elbawab

Associate professor

Imam Abdulrahman Bin Faisal University

Study Sites (1)

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