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Study Compares Pneumothorax Recurrence: Absorbable Mesh vs. Pleurectomy in Primary Spontaneous Pneumothorax.

NCT06413966 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-05-14

No results posted yet for this study

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).

Conditions

  • Primary Spontaneous Pneumothorax

Interventions

PROCEDURE

Partially absorbable mesh

\- In this group, after bullectomy or blebectomy, partially absorbable mesh (ULTRAPRO size 15 x 15 cm, Ethicon) will be prepared and inserted into the pleural cavity through one of the working ports and placed at the apical part of the thoracic cage (over the staple line) using fixation device (ProTack™ 5 mm fixation device, Medtronic).

PROCEDURE

Apical pleurectomy

\- In apical pleurectomy group, after bullectomy or blebectomy, the parietal surface from the apex to the fifth rib was dissected and abraded using a curved dissector with a diathermy scratch pad. Abrasion was done until a uniform aspect of bloody pleura was obtained.

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Apichat Tantraworasin, M.D, Ph.D. · Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06413966 on ClinicalTrials.gov