Thoracoscopic Bullectomy Versus Thoracoscopic Bullectomy With Pleurodesis in Primary Spontaneous Pneumothorax

NCT03943069 | Unknown DMC

• 1 other identifier: ThorSurg_2014-04
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Recurrence of pneumothorax

  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.

  6 months

Secondary Outcomes (2)

• Drainage and air leak

  1 week

• Postoperative Pain

  1 week

Study Arms (1)

Patient with PSP

EXPERIMENTAL

Patient who will be admitted with primary spontaneous pneumothorax.

Procedure: Thoracoscopic bullectomy alone; Procedure: Thoracoscopic bullectomy with pleurodesis

Interventions

Thoracoscopic bullectomy alone PROCEDURE

Thoracoscopic stapling of emphysematous like changes (ELCs) to control the air leak from the lung bullae.

Also known as: VATS Bullectomy

Patient with PSP

Thoracoscopic bullectomy with pleurodesis PROCEDURE

Thoracoscopic stapling of emphysematous like changes (ELCs) to control the air leak from the lung bullae.in addition to mechanical pleurodesis.

Also known as: VATS Bullectomy with pleurodesis

Patient with PSP

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Hemopneumothorax
• Previous thoracic surgical intervention
• Patient undergoing thoracotomy

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead
• King Fahad Specialist Hospital Dammam: collaborator
• Qatif Central Hospital: collaborator
• Johns Hopkins Aramco Healthcare: collaborator

Study Sites (1)

Imam Abdulrahman bin Faisal University

Dammam, Eastern Province, 34212, Saudi Arabia

RECRUITING

Related Publications (8)

• Noppen M, De Keukeleire T. Pneumothorax. Respiration. 2008;76(2):121-7. doi: 10.1159/000135932. Epub 2008 Jun 26.

  PMID: 18708734 BACKGROUND

• Grundy S, Bentley A, Tschopp JM. Primary spontaneous pneumothorax: a diffuse disease of the pleura. Respiration. 2012;83(3):185-9. doi: 10.1159/000335993. Epub 2012 Feb 15.

  PMID: 22343477 BACKGROUND

• Noppen M. Spontaneous pneumothorax: epidemiology, pathophysiology and cause. Eur Respir Rev. 2010 Sep;19(117):217-9. doi: 10.1183/09059180.00005310.

  PMID: 20956196 BACKGROUND

• Huh U, Kim YD, Cho JS, I H, Lee JG, Lee JH. The Effect of Thoracoscopic Pleurodesis in Primary Spontaneous Pneumothorax: Apical Parietal Pleurectomy versus Pleural Abrasion. Korean J Thorac Cardiovasc Surg. 2012 Oct;45(5):316-9. doi: 10.5090/kjtcs.2012.45.5.316. Epub 2012 Oct 9.

  PMID: 23130305 BACKGROUND

• Noppen M, Baumann MH. Pathogenesis and treatment of primary spontaneous pneumothorax: an overview. Respiration. 2003 Jul-Aug;70(4):431-8. doi: 10.1159/000072911.

  PMID: 14512683 BACKGROUND

• Alayouty HD, Hasan TM, Alhadad ZA, Omar Barabba R. Mechanical versus chemical pleurodesis for management of primary spontaneous pneumothorax evaluated with thoracic echography. Interact Cardiovasc Thorac Surg. 2011 Nov;13(5):475-9. doi: 10.1510/icvts.2011.270280. Epub 2011 Aug 9.

  PMID: 21828109 BACKGROUND

• Zhang Z, Du L, Feng H, Liang C, Liu D. Pleural abrasion should not routinely preferred in treatment of primary spontaneous pneumothorax. J Thorac Dis. 2017 Apr;9(4):1119-1125. doi: 10.21037/jtd.2017.03.124.

  PMID: 28523168 RESULT

• Horio H, Nomori H, Kobayashi R, Naruke T, Suemasu K. Impact of additional pleurodesis in video-assisted thoracoscopic bullectomy for primary spontaneous pneumothorax. Surg Endosc. 2002 Apr;16(4):630-4. doi: 10.1007/s00464-001-8232-5. Epub 2002 Jan 9.

  PMID: 11972203 RESULT

MeSH Terms

Interventions

Pleurodesis

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Hatem Y El-Bawab, Doctorate

CONTACT

+966537395536; HYBawab@iau.edu.sa

Yasser M Aljehani

CONTACT

+966542253333; yjehani@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: May 9, 2019
• Study Start: November 1, 2019
• Primary Completion: November 25, 2022
• Study Completion: August 25, 2023
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years

Locations

SA (1)