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

NCT06413966 | Recruiting

• 1 other identifier: SUR-2566-0393
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Operative time (minute)

  From time of skin incision until time of skin closure during intraoperative period

• Postoperative chest tube duration (days)

  From date of first postoperative day until the date of chest drain removal, assessed up to 30 days

• Postoperative pain (pain score)

  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

• Composite postoperative complications

  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.

• Hospitalization cost (baht)

  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

Study Arms (2)

Partially absorbable mesh coverage group

EXPERIMENTAL

\- 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.

Procedure: Partially absorbable mesh

Apical pleurectomy group

ACTIVE COMPARATOR

\- 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

Procedure: Apical pleurectomy

Interventions

Partially absorbable mesh PROCEDURE

\- 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).

Partially absorbable mesh coverage group

Apical pleurectomy PROCEDURE

\- 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.

Apical pleurectomy group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of surgery, Faculty of medicine, Chiang Mai University Hospital

Chiang Mai, Chaing Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Apichat Tantraworasin, M.D, Ph.D.

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Apichat Tantraworasin, M.D, Ph.D.

CONTACT

+6653945767; ohm_med@hotmail.com

Somcharoen Saeteng, M.D.

CONTACT

+6653945767; tengearneae@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * Participants (Double-blinded) and Assessor (nurse who will be assigned for collecting perioperative and postoperative results after surgery) * After obtaining informed consent and the patient's agreement to participate in the study, the patients will be allocated block sizes of four and computer-generated random numbers in sequential order within opaque envelopes that are sealed. The allocation process follows a 1:1 ratio. * Those sealed envelopes were kept by the researcher. On the day of operation, after video-assisted thoracoscopic blebectomy/bullectomy will be done, a randomized envelope will be opened by the scrub nurse to determine which additional method would be used between partially absorbable mesh and apical pleurectomy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: May 14, 2024
• Study Start: May 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

TH (1)