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Thoracoscopic Bullectomy Versus Thoracoscopic Bullectomy With Pleurodesis in Primary Spontaneous Pneumothorax

NCT03943069 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2020-11-06

No results posted yet for this study

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

Interventions

PROCEDURE

Thoracoscopic bullectomy alone

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

PROCEDURE

Thoracoscopic bullectomy with pleurodesis

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

Sponsors & Collaborators

  • King Fahad Specialist Hospital Dammam

    collaborator OTHER

  • Qatif Central Hospital

    collaborator OTHER

  • Johns Hopkins Aramco Healthcare

    collaborator OTHER

  • Imam Abdulrahman Bin Faisal University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-11-25
Completion
2023-08-25

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943069 on ClinicalTrials.gov