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

Not Applicable

Completed

• Conditions: Nasal Injury
• Interventions: Procedure: Piezosurgery osteotomy; Procedure: Conventional osteotomy

• Registration Number: NCT05807087
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piezosurgery	Piezosurgery osteotomy	-
Mechanical Osteotomy	Conventional osteotomy	-

Primary Outcome Measures

Name	Time	Method
Visual analogue score	immediately after procedure	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')
Operative time	During procedure	Operation duration will be calculated
Change in periorbital edema	Baseline and 1 week	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.
Change in eccyhmosis	Baseline and 1 week	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.

Secondary Outcome Measures

Name	Time	Method
Functional - aesthetic outcome	immediately after procedure	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.

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Azarita, Egypt