Pleurectomy Versus Pleural Abrasion in Patients With Spontaneous Pneumothorax

NCT05407974 | Unknown

• 1 other identifier: Pleurectomy Versus abrasion
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumothorax refers to air in the pleural cavity (i.e. interspersed between the lung and the chest wall).1 Primary spontaneous pneumothorax (PSP) mostly occurs in healthy individuals without an apparent cause, probably due to the rupture of subpleural blebs located mostly on the apex of the lung or the apical segment of the lower lobe. Compared to PSP, a secondary spontaneous pneumothorax (SSP) occurs in the setting of underlying pulmonary disease, like COPD.2 Surgical treatment involves resection of apical bleb disease and pleurodesis which could be chemical or mechanical. Mechanical pleurodesis accomplished either via pleurectomy or pleural abrasion.3 In this study, we aim to compare the efficiency and recurrence risk of pleural abrasion versus pleurectomy in patients with Spontaneous pneumothorax.

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (1)

• Incidence of Recurrence

  Incidence of recurrence of pneumothorax is measured by clinical examination and chest x ray done at 3 and at 6 month postoperative

  6 months

Study Arms (2)

Pleural abrasion Group

EXPERIMENTAL

Mechanical pleural abrasion will be performed by rubbing the parietal pleura with gauze or a cleaning pad.

Procedure: pleurectomy

pleurectomy group

EXPERIMENTAL

Pleurectomy will be performed by a small piece of gauze on grasper. The aim of pleurectomy is to remove the parietal pleural especially above the areas with blebs or bullae.

Procedure: pleurectomy

Interventions

pleurectomy PROCEDURE

All patients will undergo resection of apical blebs with simultaneous pleurectomy or pleural abrasion. Chest tube will be inserted in the pleural cavity and maybe connected on low-grade suction for first 24 h according to type of pneumothorax \& surgeons' preference, after which the suction is disconnected. Post Operatively both groups will be compared regarding the postoperative drainage amount, persistence of air leak (chest tube removal time), length of hospital stay, mortality and risk of recurrence. Follow up Chest x-ray will be done immediate postoperatively, then each patient will be followed up after 6 months.

Also known as: bullectomy

Pleural abrasion Group; pleurectomy group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients presented with spontaneous pneumothorax; primary or secondary.
• Age: all age groups are included
• Approach: Video assisted thoracoscopic surgery

You may not qualify if:

• \- Refusal of procedure or participation in the study.
• Patients with acquired pneumothorax (eg. Traumatic)
• Patients with history of previous thoracic surgery on the same side of chest.
• Approach: any open thoracotomy approach or switching from VATS to open thoracotomy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, 11511, Egypt

RECRUITING

Related Publications (3)

• Ocakcioglu I, Kupeli M. Surgical Treatment of Spontaneous Pneumothorax: Pleural Abrasion or Pleurectomy? Surg Laparosc Endosc Percutan Tech. 2019 Feb;29(1):58-63. doi: 10.1097/SLE.0000000000000595.

  PMID: 30499890 BACKGROUND

• Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii39-52. doi: 10.1136/thorax.58.suppl_2.ii39. No abstract available.

  PMID: 12728149 BACKGROUND

• Joharifard S, Coakley BA, Butterworth SA. Pleurectomy versus pleural abrasion for primary spontaneous pneumothorax in children. J Pediatr Surg. 2017 May;52(5):680-683. doi: 10.1016/j.jpedsurg.2017.01.012. Epub 2017 Jan 27.

  PMID: 28168984 BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Abdelfatah E Abugabal

  Ainshams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelfatah E Abugabal

CONTACT

+201098064416; abdelfatah_abugabal@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: June 7, 2022
• Study Start: October 3, 2021
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)