NCT00467714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 18, 2008

Status Verified

November 1, 2008

Enrollment Period

1.7 years

First QC Date

April 29, 2007

Last Update Submit

November 17, 2008

Conditions

Nose Deformities, Acquired

Keywords

RHINOPLASTY ,ESTHETIC SURGERY

Outcome Measures

Primary Outcomes (1)

  • TIP ROTATION

    6 month after surgery

Secondary Outcomes (1)

  • TIP PROJECTION

    6 month after surgery

Study Arms (1)

1

NO INTERVENTION

2.5 cm Cartilage as columella strut

Procedure: rhinoplasty

Interventions

rhinoplastyPROCEDURE

COLUMELLA STRUT PLACEMENT

Also known as: no other name
1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • RHINOPLASTIC PATIENTS

You may not qualify if:

  • REVISION SURGERY,
  • INCOMPLETE STRIP,
  • FACIAL ANOMALY

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Hospital

Tehran, Tehran Province, 19799, Iran

Location

MeSH Terms

Conditions

Nose Deformities, Acquired

Interventions

Rhinoplasty

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsNasal Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • mohmad sadeghi, professor

    deputy of research of tehran university medical science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2007

First Posted

May 1, 2007

Study Start

February 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 18, 2008

Record last verified: 2008-11

Locations

IR(1)