Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202505573249191 Date of Approval: 19/05/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Open Septorhinoplasty
Official scientific title Comparative Study of Peizosurgery and Traditional Osteotomy in Open Septorhinoplasty
Brief summary describing the background and objectives of the trial Lateral osteotomy is a key component of rhinoplasty, particularly when correcting nasal deformities or narrowing the nasal dorsum after hump removal. While effective in reshaping the nasal bones and addressing open roof deformities, traditional lateral osteotomy techniques often result in complications such as bleeding, bruising (ecchymosis), and prolonged postoperative swelling (edema). These adverse effects are largely due to soft tissue trauma and nasal mucosal injury caused by conventional mechanical instruments. To overcome these limitations, piezosurgery has emerged as an innovative technique that uses ultrasonic vibrations to cut bone with high precision while preserving adjacent soft tissues. This approach minimizes intraoperative bleeding, reduces postoperative edema and ecchymosis, and improves patient comfort and recovery. Piezosurgery is particularly valuable in delicate surgical areas where bone lies close to soft tissue, such as the nasal pyramid. Despite these advantages, literature reports vary on whether piezosurgery significantly outperforms conventional methods in all postoperative outcomes. The present study was conducted to compare piezosurgery with traditional osteotomy techniques in open septorhinoplasty. The investigation focused on evaluating each method’s reliability, complication rates, and both functional and aesthetic results to determine the most effective approach for lateral nasal osteotomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 14/12/2021
Actual trial start date 14/12/2021
Anticipated date of last follow up 10/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional Osteotomy in Open Septorhinoplasty once duration of the operation According to accepted surgical literature, a 2 mm osteotome was employed in the traditional osteotomy group. An exterior plaster cast was placed to stabilize and safeguard the nasal pyramid following each treatment, and nasal splints were placed intranasally 20 Active-Treatment of Control Group
Experimental Group Piezosurgery technique in Open Septorhinoplasty once duration of the operation All patients in the piezosurgery group had open rhinoplasty while maintaining general anesthesia. At the lateral nasal wall level and intranasally, a local anesthetic infiltration was performed using a 2% lidocaine and epinephrine mixture at a dosage of 1:100,000. After completing the median nasal osteotomy and removing the dorsal nasal hump, a 2 mm incision was made from the medial canthus about 10 mm inferiorly and medially. This incision passed through the periosteum, superficial musculoaponeurotic system, and skin. Avoiding the necessity to make a subperiosteal tunnel, the Piezosurgery Medical Device (PMD) scalpel's small, curved tip was inserted into this incision and placed along the desired osteotomy border. The vibrating PMD scalpel moved steadily and gently along the osteotomy pathway after it was turned on. With little manual force, osteotomy started at the site of the incision and, when both sides were finished, produced a greenstick fracture at the canthal level. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
at least eighteen years old with external nasal deformities and chronic nasal obstruction associated with septal deviation with or without a history of nasal trauma Patients with a history of bleeding tendency, received anticoagulant drugs, Individuals with uncontrolled systemic disorders such as diabetes mellitus and hypertension patients with septal perforation, recent nasal trauma within the past three months, adenoid hypertrophy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/12/2021 Faculty of Medicine Al Azhar University Assiut
Ethics Committee Address
Street address City Postal code Country
Al Azhar University Assiut Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative Edema and Ecchymosis Severity, Pain Levels, and Mucosal Integrity first day , and the seventh day after the operation
Secondary Outcome Operative Time, intraoperative and Postoperative Complications as hemorrhage, mucosal laceration, or infection rates, Patient Satisfaction, and Aesthetic and Functional Outcomes. first day, and seventh day after operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
otorhinolaryngology department AlAzhar University Hospital Al Azhar University Hospital Assiut Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar University Hospital Assiut Al-Azhar University Hospital Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University hospital Al Azhar University hospitals Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Abd El Rahim tarek_assiut@yahoo.com +201000948087 Abotig Typical hospital
City Postal code Country Position/Affiliation
Assiut Abotig Egypt spescialist of otorhinolaryngology
Role Name Email Phone Street address
Public Enquiries Sabry Eissa sabryissa19@gmail.com +201016450072 AlAzhar University, hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer of otorhinolaryngology AlAzhar university assiut
Role Name Email Phone Street address
Scientific Enquiries Mohammed Wafaea moh123@yahoo.com +201224029464 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Professor of otorhinolaryngology Al Azhar university Assiut
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results of this study will be available after deidentification (text, tables, figures) Informed Consent Form,Study Protocol data will be available 3 months and up to 12 months after article publications qualified persons only
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 19/05/2025 PACTR Admin 14 Dec 2021