The Effect of Packing in Post Operative Management of FESS - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00793117

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 IV

MedlinePlus related topics: Sinusitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess

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

Primary Outcome Measures:

complication [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	66
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793117

Contacts

Contact: babak saedi, md

989123872469

saedi@tums.ac.ir

Locations

Iran, Islamic Republic of
Imam Khomaimee hospital	Recruiting
tehran, Iran, Islamic Republic of, 19799
Contact: babak saedi 989123872569 saedi@tums.ac.ir
Principal Investigator: babak saedi, md

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Principal Investigator:

babak saedi

ENT research center of tehran university

More Information

Responsible Party:	tehran university of medical scince ( otolaryngologic group of tehran university )
Study ID Numbers:	BS-87-01-48-6841, 87-01-48-6844
Study First Received:	November 15, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793117
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:

chronic sinusitis
FESS
packing

Study placed in the following topic categories:

Respiratory Insufficiency
Otorhinolaryngologic Diseases
Nasal Obstruction
Respiratory Tract Diseases
Epistaxis

Respiration Disorders
Airway Obstruction
Pain
Sinusitis
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009