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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Thailand
Department of surgery, Faculty of medicine, Chiang Mai University Hospital
RECRUITING
Chiang Mai
Contact Information
Primary
Apichat Tantraworasin, M.D, Ph.D.
ohm_med@hotmail.com
+6653945767
Backup
Somcharoen Saeteng, M.D.
tengearneae@gmail.com
+6653945767
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 24
Treatments
Experimental: Partially absorbable mesh coverage group
\- This group of patient will receive partially absorbable mesh coverage (ULTRAPRO size 15 x 15 cm, Ethicon) as an additional procedure after VATs to blebectomy/bullectomy.
Active_comparator: Apical pleurectomy group
\- This group of patient will receive standard surgical treatment that is used at Maharaj Nakorn Chiangmai Hospital, which is blebectomy or bullectomy with apical pleurectomy under video-assisted thoracoscopic approach
Related Therapeutic Areas
Sponsors
Leads: Chiang Mai University

This content was sourced from clinicaltrials.gov