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Trial record 6 of 25 for:    "Pleural Disease" | "Anti-Bacterial Agents"

Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax

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ClinicalTrials.gov Identifier: NCT00270751
Recruitment Status : Unknown
Verified August 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2005
Last Update Posted : August 7, 2006
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE December 26, 2005
First Posted Date  ICMJE December 28, 2005
Last Update Posted Date August 7, 2006
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2005)
Recurrence rate of pneumothorax after thoracoscopic operation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00270751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2006)
  • The short-term results (Pain level, chest tube duration, hospital stay, etc)
  • Complication rate
  • Long-term results: residual pain
  • Long-term pulmonary function test
Original Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2005)
  • 1. The short-term results (Pain level, chest tube duration, hospital stay, etc)
  • 2. Complication rate
  • 3. Long-term results: residual pain
  • 4. Long-term pulmonary function test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax
Official Title  ICMJE Comparison of Pleural Abrasion Plus Minocycline Pleurodesis Versus Apical Pleurectomy After Thoracoscopic Bullectomy for High Recurrent Risk Patients With Primary Spontaneous Pneumothorax: A Prospective Randomized Trial.
Brief Summary Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.
Detailed Description Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumothorax
Intervention  ICMJE
  • Procedure: 1 apical pleurectomy
  • Procedure: 2 pleural abrasion + minocycline pleurodesis
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: December 26, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 15 and 50 years old Undergoing thoracoscopic bullectomy Had multiple blebs or no identified blebs during the operation

Exclusion Criteria:

  • With underlying pulmonary disease With major systemic disease or acute infection Underwent ipsilateral operation previously Bleb number = 1 or 2
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00270751
Other Study ID Numbers  ICMJE 31MD02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Study Chair: Yung-Chie Lee, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
Study Director: Jin-Shing Chen, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
PRS Account National Taiwan University Hospital
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP