Comparing two surgical methods for treating recurrent pneumothorax

Comparison on Recurrence Rate of Pneumothorax Between Mesh and Apical Pleurectomy After Video-Assisted Thoracoscopic Blebectomy/Bullectomy for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial (Pilot Study)

This study is testing whether two different surgical methods can help prevent repeated lung collapses in people with a specific type of lung condition.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Chiang Mai University (other)
• Locations: 1 site (Chiang Mai, Chaing Mai)
• Trial ID: NCT06413966 on ClinicalTrials.gov

What this trial studies

This prospective, randomized controlled trial aims to evaluate the incidence of post-operative recurrent pneumothorax within one year after video-assisted thoracoscopic surgery. Patients diagnosed with primary spontaneous pneumothorax will be randomly assigned to receive either apical pleurectomy or partially absorbable mesh coverage. The study will assess the effectiveness of these two surgical interventions in preventing recurrence of pneumothorax. Participants will be enrolled at Maharaj Nakorn Chiangmai Hospital in Thailand, and informed consent will be obtained prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates are patients aged 20 and older with a diagnosis of primary spontaneous pneumothorax requiring surgical intervention.

Not a fit: Patients with contraindications for surgery or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical options for patients with primary spontaneous pneumothorax, reducing the rate of recurrence.

How similar studies have performed: Previous studies have shown varying success rates with surgical interventions for pneumothorax, but this specific comparison of techniques is novel.

Eligibility criteria

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

Where this trial is running

Chiang Mai, Chaing Mai

• Department of surgery, Faculty of medicine, Chiang Mai University Hospital — Chiang Mai, Chaing Mai, Thailand (RECRUITING)

Study contacts

• Principal investigator: Apichat Tantraworasin, M.D, Ph.D. — Chiang Mai University
• Study coordinator: Apichat Tantraworasin, M.D, Ph.D.

Conditions: Primary Spontaneous Pneumothorax, Video-assisted Thoracoscopic Surgery, Apical pleurectomy, Partially absorbable mesh coverage, Recurrence rate of pneumothorax