Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pn… (NCT06413966) | Clinical Trial Compass
RecruitingNot Applicable
Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pneumothorax.
Thailand24 participantsStarted 2024-05-01
Plain-language summary
This is a prospective, randomized controlled trial (pilot study) that aims to determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomy/bullectomy with either apical pleurectomy or partially absorbable mesh, as well as to assess the efficacy in preventing post-operative recurrence pneumothorax. Patients, aged more than or equal 20-year-old, with the diagnosis of primary spontaneous pneumothorax, who require video-assisted thoracoscopic surgery at Maharaj Nakorn Chiangmai Hospital, Chiang Mai University, Chiang Mai, Thailand, will be enrolled into this study. The inform consent will be obtained before the enrollment. Patients will be randomized to two groups; Partially absorbable mesh coverage group (intervention group) and Apical pleurectomy group (control group).
Who can participate
Age range20 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients (both sex) with first or second episode of primary spontaneous pneumothorax (either ipsilateral or contralateral) who have meet at least one of the following criteria for surgery below.
* Persistent air leakage five days following the insertion of a chest tube to treat spontaneous pneumothorax3,26 or failure of lung re-expansion2
* Air leakage after surgery will be categorized into 4 grades based on Robert David Cerfolio Classification System27; Grade1 inspire and expire air leakage (continuous air leakage), Grade 2 inspire air leakage, Grade 3 expire air leakage and Grade 4 forced expire air leakage.
* No matter grade of air leakage, once patients have any grade of air leakage of 4-5 days after chest drain insertion, they will be diagnosed with persistent air leakage.
* Hemopneumothorax
* Bilateral pneumothorax
* Visible blebs on the initial plain chest film or computed tomography
* Professions at risk (Aircraft personals, divers)
* Aged more than or equal to 20 years old.
Exclusion Criteria:
* Hemothorax or Pneumothorax that requires bilateral thoracic surgery.
* Previous ipsilateral thoracic operation
* Other serious concomitant illnesses or medical conditions e.g., Congestive heart failure, unstable angina, history of myocardial infarction within 1 year prior to entering this study.
* History of significant neurologic or psychiatric disorder
What they're measuring
1
Recurrence rate of pneumothorax after operation
Timeframe: From date of surgery until the date of last follow-up, assessed at least 12 months and up to 24 months