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OpenTrials
Completed

NCT Number: NCT01852643

Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty

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.

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Key information

Conditions

Rhinoplasty Techniques

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Plastic Surgery, Alzahra Hospital

Isfahan, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spreader graft

Procedure

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

Lateral crural overlay

Procedure

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

Primary outcomes

  1. Nasal flow

    Time frame: 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).

  2. Nasal resistance

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Determine and Compare the Finding of Rhinomanometry Before and After Treatment in Two Ways of Rhinoplasty Surgery (Spreader Graft and Lateral Crural Over Lapping)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 14, 2013
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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