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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:
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)
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A- Thick skin, 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 | Patients with mean nasal soft tissue envelope thickness > 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation |
| |
| Group 2A- Thin skin, 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 | Patients with mean nasal soft tissue envelope thickness < 4 mm undergoing piezosurgery assisted osteotomy procedure during rhinoplasty operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endonasal osteotomy | Procedure | Patients will undergo median-oblique and lateral osteotomy, with conventional 2 mm guarded, straight osteotome. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the mean nasal soft tissue envelope thickness measurements of rhinoplasty patients at postoperative 10th month | 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 | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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18-65 year, males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isil Taylan Cebi, M.D | Contact | 00905072352256 | drisiltaylan@hotmail.com | |
| Abdullah Karatas, Assoc. Prof | Contact | 00905326230218 | akrts2000@yahoo.ca |
| Name | Affiliation | Role |
|---|---|---|
| Isil Taylan Cebi, M.D | Haseki Training and Research Hospiral | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haseki Training and Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31307096 | Background | Gode S, Ozturk A, Kismali E, Berber V, Turhal G. The Effect of Platelet-Rich Fibrin on Nasal Skin Thickness in Rhinoplasty. Facial Plast Surg. 2019 Aug;35(4):400-403. doi: 10.1055/s-0039-1693436. Epub 2019 Jul 15. | |
| 33867511 | Background | Erdur ZB, Oktem F, Inci E, Yener HM, Ustundag A. Effect of Nasal Soft-Tissue Envelope Thickness on Postoperative Healing Process Following Rhinoplasty. J Craniofac Surg. 2021 Sep 1;32(6):2193-2197. doi: 10.1097/SCS.0000000000007697. |
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| Piezo assisted osteotomy | Device | Piezo is a system for cutting bone with micrometric ultrasonic piezoelectric vibrations, with varying frequency and cutting energy. The device consists of a platform with a powerful piezoelectric hand piece and employs a functional frequency between 25-29 kHz. The device is fitted with a cooling irrigation system with a 0-60 cc/min variable sterile solution flow. Specific inserts and scalpels act in a linear vibration pattern, with a spatial range between 60 and 210 microns, moved by an ultrasonic power that exceeds 5 watts, reaching up to 16 watts. |
|
| 27628964 | Background | Stenner M, Koopmann M, Rudack C. Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):855-860. doi: 10.1007/s00405-016-4296-7. Epub 2016 Sep 15. |
| 32320977 | Background | Tsikopoulos A, Tsikopoulos K, Doxani C, Vagdatli E, Meroni G, Skoulakis C, Stefanidis I, Zintzaras E. Piezoelectric or Conventional Osteotomy in Rhinoplasty? A Systematic Review and Meta-Analysis of Clinical Outcomes. ORL J Otorhinolaryngol Relat Spec. 2020;82(4):216-234. doi: 10.1159/000506707. Epub 2020 Apr 22. |
| 30243555 | Background | Kurt Yazar S, Serin M, Rakici IT, Sirvan SS, Irmak F, Yazar M. Comparison of piezosurgery, percutaneous osteotomy, and endonasal continuous osteotomy techniques with a caprine skull model. J Plast Reconstr Aesthet Surg. 2019 Jan;72(1):107-113. doi: 10.1016/j.bjps.2018.08.025. Epub 2018 Sep 4. |
| ID | Term |
|---|---|
| D009667 | Nose Deformities, Acquired |
| D004487 | Edema |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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