The Effect of Packing in Post Operative Management of FESS | NCT00793117

Studies
The Effect of Packing in Post Operative Management of FESS

NCT00793117

Sponsor

Tehran University of Medical Sciences

Status

Completed

Last Update Posted

Jun 5, 2012Estimated

Enrollment

66Actual

Phase

Phase 4

Conditions

Epistaxis
Nasal Obstruction
Pain

Interventions

packing

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
87-01-48-6844

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 15, 2008

First Submission Date that Met QC Criteria

Nov 18, 2008

First Posted Date

Nov 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2012

Last Update Posted Date

Jun 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Babak Saedi, associate Professor, Tehran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Tehran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	poly vinil chloride packing	Procedure: packing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
packing	Procedure	packing in middle meatus for duration of 5 day	1

Measure	Description	Time Frame
complication		6 month

Eligibility Module

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-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
babak saedi	Tehran University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Khomaimee hospital		Tehran	Tehran Province	19799	Iran

Condition Browse Module

MeSH Terms

ID	Term
D004844	Epistaxis
D015508	Nasal Obstruction
D010146	Pain

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D006470	Hemorrhage

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004349	Drug Packaging

Ancestor Terms

ID	Term
D013678	Technology, Pharmaceutical
D008919	Investigative Techniques
D004345	Drug Industry
D066192	Manufacturing Industry

Browse Leaves

Not provided

Browse Branches

Not provided