Evaluation Of Cloumella Strut Effect In Tip Rotation | NCT00467714

Studies
Evaluation Of Cloumella Strut Effect In Tip Rotation

NCT00467714

Sponsor

Tehran University of Medical Sciences

Status

Completed

Last Update Posted

Nov 18, 2008Estimated

Enrollment

92Actual

Phase

Phase 4

Conditions

Nose Deformities, Acquired

Interventions

rhinoplasty

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

Status Module

Record Verification Date

Nov 2008

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

Feb 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Apr 29, 2007

First Submission Date that Met QC Criteria

Apr 30, 2007

First Posted Date

May 1, 2007Estimated

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

Nov 17, 2008

Last Update Posted Date

Nov 18, 2008Estimated

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

The role of strut in rhinoplasty has been debated for many years and many research has been made over this problem but there is no significant data for descision of surgeon, so this study was designed to evaluate the effect of columellar strut in tip projection and rotation.

Detailed Description

In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	2.5 cm Cartilage as columella strut	Procedure: rhinoplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhinoplasty	Procedure	COLUMELLA STRUT PLACEMENT	1	no other name

Measure	Description	Time Frame
TIP ROTATION		6 month after surgery

Measure	Description	Time Frame
TIP PROJECTION		6 month after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RHINOPLASTIC PATIENTS

Exclusion Criteria:

REVISION SURGERY,
INCOMPLETE STRIP,
FACIAL ANOMALY

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohmad sadeghi, professor	deputy of research of tehran university medical science	Study Director

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D009667	Nose Deformities, Acquired

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012225	Rhinoplasty

Ancestor Terms

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D059747	Nasal Surgical Procedures
D013517	Otorhinolaryngologic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided