Primary Spontaneous Pneumothorax Clinical Trial
Official title:
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 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).
Status | Recruiting |
Enrollment | 24 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of surgery, Faculty of medicine, Chiang Mai University Hospital | Chiang Mai | Chaing Mai |
Lead Sponsor | Collaborator |
---|---|
Chiang Mai University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence rate of pneumothorax after operation | Recurrence rate of ipsilateral pneumothorax at least one- year follow-up period and up to 24 months after video-assisted thoracoscopic bullectomy with either partially absorbable mesh or apical pleurectomy. Gold standard for detecting recurrent pneumothorax is chest radiography and it is defined as the presence of an ipsilateral pneumothorax of any size in the follow-up chest radiography. | From date of surgery until the date of last follow-up, assessed at least 12 months and up to 24 months | |
Secondary | Operative time (minute) | Time between skin incision to surgical wound closure, report in minutes | From time of skin incision until time of skin closure during intraoperative period | |
Secondary | Postoperative chest tube duration (days) | Duration of chest tube insertion | From date of first postoperative day until the date of chest drain removal, assessed up to 30 days | |
Secondary | Postoperative pain (pain score) | Using Visual analog scale (scale range from 0-10) | From time of immediate postoperative period until time of the patient has been discharged or date of death from any cause, whichever came first, assessed up to 30 days | |
Secondary | Composite postoperative complications | composite postoperative complications include persistent air leaks (more than or equal to 5 days) after operation, Fever, Empyema, and Pneumonia | From time of immediate postoperative until time of the patient has been discharged or date of death from any cause, whichever came first, assessed up to 30 days. | |
Secondary | Hospitalization cost (baht) | Cost during hospitalization | From the date that patient has been admitted until the date that patient has been discharged or date of death from any cause during admitted, assessed up to 30 days | |
Secondary | Postoperative pleural effusion (ml) | The amount of pleural fluid per day until it has been removed. | From date of 1st postoperative day until date of chest drain removed, assessed up to 30 days | |
Secondary | Intraoperative blood loss (ml) | Blood loss collected by anesthesiologist or surgeon | From time of skin incision until time of skin closure during operative period | |
Secondary | Dosage of morphine use after postoperative period till discharged. | The dosage of morphine using will be counted from immediate postoperative period till discharged. | From time of immediate postoperative period until time of patient discharged from hospital, assessed up to 30 days |
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