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The Effect of Packing in Post Operative Management of FESS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793117
First Posted: November 19, 2008
Last Update Posted: June 5, 2012
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.
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Epistaxis Nasal Obstruction Pain Procedure: packing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess

Further study details as provided by Babak Saedi, Tehran University of Medical Sciences:

Primary Outcome Measures:
  • complication [ Time Frame: 6 month ]

Enrollment: 66
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
poly vinil chloride packing
Procedure: packing
packing in middle meatus for duration of 5 day

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with chronic sinusitis who candid of fess

Exclusion Criteria:

  • Systemic disease
  • Corticosteroid usage counterindication
  • Immune suppresive usage
  • Choncha bollusa resection-
  Contacts and Locations
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): NCT00793117


Locations
Iran, Islamic Republic of
Imam Khomaimee hospital
Tehran, Iran, Islamic Republic of, 19799
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: babak saedi Tehran University of Medical Sciences
  More Information

Responsible Party: Babak Saedi, associate Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00793117     History of Changes
Other Study ID Numbers: BS-87-01-48-6841
87-01-48-6844
First Submitted: November 15, 2008
First Posted: November 19, 2008
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Babak Saedi, Tehran University of Medical Sciences:
chronic sinusitis
FESS
packing

Additional relevant MeSH terms:
Epistaxis
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders