Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty

Phase 2

Completed

• Conditions: Rhinoplasty Techniques
• Interventions: Procedure: Spreader graft; Procedure: Lateral crural overlay

• Registration Number: NCT01852643
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Therefore, in this study the investigators are going to compare the efficacy of spreader graft and lateral crural overlay techniques by an objective method, rhinomanometry.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-05
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-13
• Last Update Submitted: 2013-05-13
• Study First Posted: 2013-05-14
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Candidates of rhinoplasty
• Willingness to participate

Exclusion Criteria

• Having structural problems such as nasal obstruction
• History of the deformity requiring rhinoplasty of the deviated septum
• Hardening surgery
• New clinical conditions or a change in therapeutic technique
• Unwillingness to continue participating in the study
• Having no access to subjects after the operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spreader graft	Spreader graft	-
Lateral crural overlay	Lateral crural overlay	-

Primary Outcome Measures

Name	Time	Method
Nasal flow	Up to 3 months	Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).
Nasal resistance	Up to 3 months	Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).

Trial Locations

Locations (1)

Department of Plastic Surgery, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of