Comparison of Conventional Techniques & Piezosurgery in the Management of the Nasal Bony Pyramid

Prospective Randomized Study Between Conventional Techniques & Piezosurgery in the Management of Nasal Bony Pyramid

It is well-known and universally acknowledged that rhinoplasty is the most demanding procedure in facial aesthetic surgery. Postoperatively nasal osteotomies result in variable degrees of edema and ecchymosis and surgeons have tried various techniques, instruments, and postoperative methods to diminish these uncomfortable morbidities. Piezosurgery is used nowadays to decrease the incidence of injured soft tissues and vital structures passing near the osteotomy line. Its use in rhinoplasty was advocated to prevent unwanted back fractures as well as to decrease bleeding while keeping the nasal mucosa intact thus minimizing postoperative sequelae.

Study Overview

• Status: Completed
• Conditions: Nasal Injury
• Intervention / Treatment: Procedure: Conventional osteotomy; Procedure: Piezosurgery osteotomy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Azarita
    • Alexandria, Azarita, Egypt, 00203
      • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requesting aesthetic rhinoplasty, post-traumatic rhinoplasty, and post-cleft nose rhinoplasty.

Exclusion Criteria:

• Patients with severe systemic disease (American Society of Anesthesiologists physical status classification system III & IV).
• Psychological disorders.
• Female patients younger than 16 years of age and male patients younger than 18 years of age.
• Patients with autoimmune and skin diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mechanical Osteotomy	Procedure: Conventional osteotomy; The nasal skeleton was accessed using a closed approach or an open approach is done via a transcolumellar and infracartilaginous incision. Osteotomy was made using osteotomes.
Experimental: Piezosurgery	Procedure: Piezosurgery osteotomy; full exposure of the nasal bony pyramid is needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operation duration will be calculated	During procedure
Visual analogue score	The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	immediately after procedure
Change in periorbital edema	Grade 1 - No coverage of iris with eyelids, Grade 2 - Slight coverage of iris with swollen eyelids, Grade 3 - Full coverage of iris with swollen eyelids, Grade 4 - Full closure of eyes.	Baseline and 1 week
Change in eccyhmosis	Grade 1 - Eccyhmosis upto the medial one-third part of lower and /or upper eyelid, Grade 2 - Ecchymosis upto the medial two-third part of the lower and/or upper eyelid. Grade 3 - Ecchymosis up to the full length and /or upper eyelid.	Baseline and 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional - aesthetic outcome	The SCHNOS is a 10-item self-rated questionnaire that uses a Likert-like 0-5 scale ('no problem' to 'extreme problem'). The SCHNOS does not produce a combined total score, but two scores - one for each domain, an obstruction score (SCHNOS-O) and a cosmesis score (SCHNOS-C) The SCHNOS-O is calculated as a sum of scores of items 1-4 divided by 20 and multiplied by 100. The SCHNOS-C score is calculated as a sum of scores of items 5-10 divided by 30 and multiplied by 100.	immediately after procedure

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NasalBoneSurgery_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No