The Role of Spreader Flaps in Preventing of Nasal Obstruction

NCT ID: NCT01907243

Last Updated: 2013-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-04-30

Brief Summary

Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft is the gold standard. More recently, the spreader flap technique has been espoused as an alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a randomized trial setting.

Detailed Description

Rhinoplasty is a common facial plastic surgery procedure, one complication of which is nasal vault narrowing and consequent nasal obstruction. Recently, researchers have paid much attention to nasal valve area and especially to the role of upper lateral cartilage (ULC) in preserving of nasal patency, since a possible consequence of destructive techniques was permanent functional problems for patients. In addition to functional problems, it can cause some aesthetic problems such as the inverted-V deformity . Accordingly, reconstruction of the midvault after dorsal reduction has been advocated and widely adopted.

The gold standard for midvault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen . Subsequently, its usage has been widened to include repair of the valve in the unoperated nose, and its efficacy well-documented. However, it can be a time-consuming procedure that requires the harvest of septal cartilage. Therefore, some authors proposed the spreader flap as an alternative technique. While the results of the above mentioned articles proposed the efficacy of spreader flaps, none of them was a randomized trial and subjective methods were used for measurement of nasal breathing after rhinoplasty.

Nasal obstruction can be evaluated in different methods, both quantitative and subjective, the validity of each debated. For example, while the numeric form of Visual Analogue Scale (VAS) is commonly used, it is ultimately related to patients' subjective perception. Alternatively, objective evaluation of nasal patency is also of common interest to many researchers, and various methods for objective measurement exist. Among these different methods, acoustic rhinomanometry is an effective tool. However, some researchers debate the reliability of these results. Herein we examine the efficacy of the spreader flap in preventing nasal obstruction after dorsal reduction using a randomized trial with both objective and subjective measures.

Conditions

Nasal Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

spreader flap

Usage of spreader flap of upper lateral cartilage

Group Type: ACTIVE_COMPARATOR

spreader flap

Intervention Type: PROCEDURE

producing of upper lateral cartilage flap as a spreader flap

Control group

performing of rhinoplasty without spreader flap

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

spreader flap

producing of upper lateral cartilage flap as a spreader flap

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who underwent rhinoplasty

Exclusion Criteria

• revision rhinoplasty
• congenital malformations
• severe allergic rhinitis
• nasal polyposis
• sinusitis
• deviated nose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Babak Saedi

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Babak Saaedi

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Imam Khomeini Hospital

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

91--02-48-6933

Identifier Type: -

Identifier Source: org_study_id