The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty

Recruiting

• Conditions: Septum; Deviation, Congenital; Nasal Deformity, Acquired
• Interventions: Procedure: Endonasal osteotomy; Device: Piezo assisted osteotomy

• Registration Number: NCT06094348
• Lead Sponsor: Haseki Training and Research Hospital

Brief Summary

The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are:

* In which osteotomy technique the edema is lesser?

* Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?

Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.

Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)

Detailed Description

The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are:

* In which osteotomy technique the edema is lesser?

* Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?

18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded.

Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.

Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements).

Study Timeline

• Study Start: 2023-05-19
• Status Verified: 2023-10
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-04-19
• Study Completion: 2024-04-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid

Exclusion Criteria

• previous rhinoplasty/septorhinoplasty procedure
• patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time)
• use of anticoagulant drugs
• chronic / inflammatory skin disease and/or chronic skin allergies
• presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma)
• nasal beautification procedures such as dermal fillings
• use of oral and/or topical (nasal skin) corticosteroids in three months preoperatively

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1A- Thick skin, endonasal osteotomy	Endonasal osteotomy	Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation
Group 1B -Thick skin, piezo osteotomy	Piezo assisted osteotomy	Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation
Group 2A- Thin skin, endonasal osteotomy	Endonasal osteotomy	Patients with mean nasal soft tissue envelope thickness \<4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation
Group 2B- Thin skin, piezo osteotomy	Piezo assisted osteotomy	Patients with mean nasal soft tissue envelope thickness \< 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation

Primary Outcome Measures

Name	Time	Method
the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month	10 months	the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10 th month will be done by ultrasonography at four anatomic locations; these locations are nasion, rhinion, supratip and tip

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 Istanbul, Turkey