A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax

NCT00767962 | Completed

• 1 other identifier: 2007-A00342-51
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of recurrent primary spontaneous pneumothorax remains controversial and many therapeutic options exist. The aim of this study is to compare pleural symphysis by talc poudrage during medical thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.

Conditions

Pneumothorax

Keywords

recurrent primary spontaneous pneumothorax

Outcome Measures

Primary Outcomes (1)

• to show the non-inferiority of talc pleurodesis under medical thoracoscopy versus pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax

  36 months

Study Arms (2)

1

OTHER

talc pleurodesis under medical thoracoscopy

Other: talc pleurodesis under medical thoracoscopy

2

OTHER

pleurodesis under video-assisted thoracoscopy surgery

Other: pleurodesis under video-assisted thoracoscopy surgery

Interventions

talc pleurodesis under medical thoracoscopy OTHER

talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax

1

pleurodesis under video-assisted thoracoscopy surgery OTHER

pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax

2

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects :both sexes, who the age is included between 18 years and 55 years;
• Presenting a recurrence homolaterale or controlaterale of a primary spontaneous pneumothorax;
• Presenting a bilateral primary spontaneous pneumothorax
• Presenting a failure of a manual inhalation for a primary spontaneous pneumothorax;
• Presenting a persistent superior bullage at 48 am after a thoracic drainage for a spontaneous pneumothorax
• Presenting a persistent superior bullage at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;
• Presenting a persistent superior unsticking at 48 am after a thoracic drainage for a primary spontaneous pneumothorax;
• Presenting a first episode of pneumothorax spontaneous primary with risk factor of recurrence
• The unsticking must be complete or important (superior to 3 cms between the summit of the lung and the summit of the thoracic cavity or superior to 2 cms with regard to the side thoracic wall);
• Benefiting from a national insurance scheme;
• Agreeing to participate in the study, and having read, included and signed the note of information intended in patients.

You may not qualify if:

• Subjects:Presenting a traumatic pneumothorax; Presenting a pneumothorax iatrogène; Presenting a secondary spontaneous pneumothorax ( underlying pleuro-lung pathology); Presenting bubbles of emphysema of size(cutting) superior to 5 cms; presenting a pneumothorax catamenial;Presenting one of the following concomitant severe pathologies dissuading a general anesthetic or any symphysant gesture(movement): cardiac insufficiency
• Pregnant or breast-feeding Woman;
• presenting neurological disorders or psychiatric forbidding the understanding of the essay;
• Who the follow-up is impossible;
• Deprived of freedom following a court or administrative order;
• Not having signed the enlightened assent.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service d'Oncologie Thoracique- Hôpital Sainte Marguerite

Marseille, 13274, France

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Anne FRATICELLI, MD

  Assistance Publique des Hopitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

FR (1)