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The Effect of Packing in Post Operative Management of FESS

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793117
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE November 15, 2008
First Posted Date  ICMJE November 19, 2008
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
complication [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Packing in Post Operative Management of FESS
Official Title  ICMJE The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess
Brief Summary Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem. So to solve this problem this research has been designed.
Detailed Description

Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem.

Someone claimed packing is unnecessary and other one propose different material to packing after surgery. So to solve this problem this research has been designed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Epistaxis
  • Nasal Obstruction
  • Pain
Intervention  ICMJE Procedure: packing
packing in middle meatus for duration of 5 day
Study Arms  ICMJE Experimental: 1
poly vinil chloride packing
Intervention: Procedure: packing
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2008)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients with chronic sinusitis who candid of fess

Exclusion Criteria:

  • Systemic disease
  • Corticosteroid usage counterindication
  • Immune suppresive usage
  • Choncha bollusa resection-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793117
Other Study ID Numbers  ICMJE BS-87-01-48-6841
87-01-48-6844
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Babak Saedi, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: babak saedi Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date June 2012

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