search
Back to results

The Effect of Packing in Post Operative Management of FESS

Primary Purpose

Epistaxis, Nasal Obstruction, Pain

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
packing
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epistaxis focused on measuring chronic sinusitis, FESS, packing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with chronic sinusitis who candid of fess

Exclusion Criteria:

  • Systemic disease
  • Corticosteroid usage counterindication
  • Immune suppresive usage
  • Choncha bollusa resection-

Sites / Locations

  • Imam Khomaimee hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

poly vinil chloride packing

Outcomes

Primary Outcome Measures

complication

Secondary Outcome Measures

Full Information

First Posted
November 15, 2008
Last Updated
June 2, 2012
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00793117
Brief Title
The Effect of Packing in Post Operative Management of FESS
Official Title
The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis, Nasal Obstruction, Pain
Keywords
chronic sinusitis, FESS, packing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
poly vinil chloride packing
Intervention Type
Procedure
Intervention Name(s)
packing
Intervention Description
packing in middle meatus for duration of 5 day
Primary Outcome Measure Information:
Title
complication
Time Frame
6 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
babak saedi
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Khomaimee hospital
City
Tehran
ZIP/Postal Code
19799
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

The Effect of Packing in Post Operative Management of FESS

We'll reach out to this number within 24 hrs