Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty

NCT01852643 | Completed Phase 2

• 1 other identifier: 390548
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinoplasty Techniques

Keywords

Rhinoplasty; Spreader graft technique; Lateral crural overlay technique; Rhinomanometry

Outcome Measures

Primary Outcomes (2)

• Nasal flow

  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).

  Up to 3 months

• Nasal resistance

  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).

  Up to 3 months

Study Arms (2)

Spreader graft

ACTIVE COMPARATOR

Procedure: Spreader graft

Lateral crural overlay

ACTIVE COMPARATOR

Procedure: Lateral crural overlay

Interventions

Spreader graft PROCEDURE

Spreader graft technique is performed by a group of expert surgeons.

Spreader graft

Lateral crural overlay PROCEDURE

Lateral crural overlay technique is performed by a group of expert surgeons.

Lateral crural overlay

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates of rhinoplasty
• Willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Department of Plastic Surgery, Alzahra Hospital

Isfahan, Isfahan, Iran

Location

Study Officials

• Amiryousef Ahmadnia, MD

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 14, 2013
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

IR (1)