Actively Recruiting
Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pneumothorax.
Led by Chiang Mai University · Updated on 2024-05-14
24
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pneumothorax.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any gender with first or second episode of primary spontaneous pneumothorax
- Persistent air leakage lasting 5 or more days after chest tube insertion or failure of lung re-expansion
- Diagnosed with hemopneumothorax
- Diagnosed with bilateral pneumothorax
- Visible blebs on chest X-ray or CT scan
- Patients with professions at risk such as aircraft personnel or divers
- Aged 20 years or older
You will not qualify if you...
- Hemothorax or pneumothorax requiring surgery on both sides of the chest
- Previous surgery on the same side of the chest
- Serious medical conditions such as congestive heart failure, unstable angina, or recent heart attack within 1 year
- Significant neurological or psychiatric disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of surgery, Faculty of medicine, Chiang Mai University Hospital
Chiang Mai, Chaing Mai, Thailand, 50200
Actively Recruiting
Research Team
A
Apichat Tantraworasin, M.D, Ph.D.
CONTACT
S
Somcharoen Saeteng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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