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

Haseki Training and Research Hospital

Status: Enrolling

Conditions: Nasal Deformity, Acquired; Septum; Deviation, Congenital

Treatments: Procedure: Endonasal osteotomy; Device: Piezo assisted osteotomy

Study type: Observational

Funder types: Other

Identifiers

NCT06094348

Piezo vs Endonasal osteotomy

Details and patient eligibility

About

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)

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Group 1A- Thick skin, endonasal osteotomy

Description:

Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation

Treatment:

Procedure: Endonasal osteotomy

Group 1B -Thick skin, piezo osteotomy

Description:

Patients with mean nasal soft tissue envelope thickness \> 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation

Treatment:

Device: Piezo assisted osteotomy

Group 2A- Thin skin, endonasal osteotomy

Description:

Patients with mean nasal soft tissue envelope thickness \<4 mm undergoing classical endonasal osteotomy procedure during rhinoplasty operation

Treatment:

Procedure: Endonasal osteotomy

Group 2B- Thin skin, piezo osteotomy

Description:

Patients with mean nasal soft tissue envelope thickness \< 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation

Treatment:

Device: Piezo assisted osteotomy