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Surgical Management of Primary Spontaneous Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03804385
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
ahmed samir yussef, Assiut University

Brief Summary:

the different surgical management in patients with primary pneumothorax 0 Objective 1: Identify risk factors that are predictive of the need for surgical intervention.

  • Objective 2: Determine the value of management strategies in terms of hospital stay
  • Objective 3: Assess outcomes and postoperative results including symptom relive ,or recurrence or post-operative complications .

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: intercostal tube Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Spontaneous Pneumothorax and Different Types of Surgical Management
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : January 30, 2021


Arm Intervention/treatment
intercostal tube
insertion of intercostal tube is surgical operation used in pneumothorax
Procedure: intercostal tube
surgical operation




Primary Outcome Measures :
  1. Duration of Intercostal tube in days [ Time Frame: 2 weeks ]
    last more in open thoracotomy

  2. Duration of air leakage in days [ Time Frame: 2 weeks ]
    last more in intercostal tube than in open thoracotomy

  3. recurrence after one year [ Time Frame: one year ]
    by radiological intervention on after one year follow up

  4. pain score [ Time Frame: 1 week ]
    high pain score in open thoracotomy than in intercostal tube



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presented with primary pneumothorax at Assiut University Hospital patients above 18 years and less 40 years Male or Females

Exclusion Criteria:

Patients with other chest pathology including :

  • emphysema
  • asthma,
  • acute or chronic infections
  • lung cancer,
  • congenital diseases including( cystic fibrosis, catamenial pneumothorax, or lymphangioleiomyomatosis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804385


Contacts
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Contact: Mohamed Abdel-kader Osman Ahmed, MHD +201062226639 osman@med.aun.edu.eg
Contact: Mohamed Ahmed Khalil Salama Ayyad, MHD +201002001932 ayyad@aun.edu.eg

Locations
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Egypt
Faculty of Medicine Assiut Univeresity
Assiut, Egypt, 71621
Contact: Mohamed Abdel-kader Osman Ahmed, MHD       osman@med.aun.edu.eg   
Contact: Mohamed Ahmed Khalil Salama Ayyad, MHD    01002001932    ayyad@aun.edu.eg   
School of Medicine Assiut Univeresity
Assiut, Egypt, 71621
Contact: Mohamed Abdel-kader Osman Ahmed, MHD       osman@med.aun.edu.eg   
Contact: Mohamed Ahmed Khalil Salama Ayyad, MHD    01002001932    ayyad@aun.edu.eg   
Sponsors and Collaborators
Assiut University

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Responsible Party: ahmed samir yussef, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03804385    
Other Study ID Numbers: Pneumothoracic
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases