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The Effect of Packing in Post Operative Management of FESS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00793117
First received: November 15, 2008
Last updated: June 2, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess

Resource links provided by NLM:


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

Primary Outcome Measures:
  • complication [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 15, 2008
Last Updated: June 2, 2012
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014