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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202501773129062 Date of Registration: 22/01/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Functional and Aesthetic Outcomes in Different Methods of Open Septorhinoplasty
Official scientific title Functional and Aesthetic Outcomes in Different Methods of Open Septorhinoplasty
Brief summary describing the background and objectives of the trial Rhinoplasty is a common surgical procedure that requires a high level of skill and expertise from surgeons due to its complex technical nuances. The aim of this work was to explore the functional and aesthetic outcomes in different methods of open septorhinoplasty.
Type of trial Observational
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 Treatment: Surgery
Anticipated trial start date 26/12/2023
Actual trial start date 26/12/2023
Anticipated date of last follow up 26/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group open rhinoplasty once followup for 6 months The contemporary method of open rhinoplasty emphasizes the conservation of cartilage and gradual modifications to the cartilage and bone structure. The operation began by delineating a V-shaped trans-columellar incision using a marking pen, which was then joined to the bilateral marginal incisions located just below the lower edge of the lateral crura. The nose was anesthetized with local anesthetic (1% lignocaine) and adrenaline (1:100,000) utilizing a 27-gauge needle. Infiltration was performed at the sites located between the upper lateral and lower lateral nasal cartilage, across the dorsum of the nose, extending into the area of the infraorbital nerve. The thin vestibular skin of the columellar flap that covers the medial crura was elevated using dissecting scissors. By placing the scissors under the columellar extension of the marginal incision, the dissection under the musculoaponeurotic layer was conducted towards the middle on one side. The same action was repeated on the other side. Next, the columellar flap was carefully separated from the lower edge of the medial and intermediate crura. The posterior part of the lateral crura was uncovered and dissection continued towards the cephalic direction.The nasal septum was accessed by separating the tissue between the medial crura of the lower lateral cartilage. The columellar strut was used to preserve the necessary tip projection. The graft was inserted into a clearly defined space between the crura and secured with mattress sutures positioned above the angle formed by the medial and intermediate crura to preserve the columellar-lobular angle. Intranasal splint fixation and external splint application were done. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 18 years and above both genders, with signs and symptoms of external nasal deformities, persistent nasal obstruction owing to septum deviation and nasal valve collapse, nasal obstruction not responding to medical therapy for > 6 months. patients with a history of bleeding disorders, history of systemic disorders such as DM and HTN, history of operation in the last 6 months, sinonasal tumors, septal perforation, acute nasal trauma in the past 3 months and adenoid hypertrophy. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 35 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 10/01/2021 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 assessing the cosmetic satisfaction of patients 1 weak, and 1 month after the operation
Secondary Outcome Assessing the functional and different side effects after rhinoplasty 6 months after the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Otolaryngology department Al Azhar University Hospital Assiut Al Azhar University Hospital Assiut Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal Al-Azhar University, faculty of medicine, Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor A lAzhar University hospital Al Azhar University hospital Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Magdy El Nagar elnagarmagdy19@gmail.com +201020815756 AlAzhar University, hospital, Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Mahmoud Elawamry tabeb_garrah83@yahoo.com +20127574926 AlAzhar University, hospital, Assiut
City Postal code Country Position/Affiliation
Assiut Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Sabry Eisa Sabryissa199@gmail.com +201016450072 AlAzhar University, hospital, Assiut
City Postal code Country Position/Affiliation
Assiut Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the individual participant data that underlie the results of this study after deidentification (text, tables, figures) will be 3available on request 12 months after publication of the article. request send to e-mail: elnagarmagdy19@gmail.com Clinical Study Report,Statistical Analysis Plan,Study Protocol 1 year after the end of the study only qualified personnel has the right to request or review the study
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 04/12/2024 PACTR Admin 26 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/12/2024 as requested by the trial reviewer TRUE, Faculty of Medicine Al Azhar University Assiut, Al Azhar University Assiut, Assiut, 71511, Egypt, , 10 Jan 2021, +2088214803, med.ast.b@azhar.edu.eg, 32056_30281_4737.pdf TRUE, Faculty of Medicine Al Azhar University Assiut, Al Azhar University Assiut, Assiut, 71511, Egypt, , 10 Jan 2021, +2088214803, med.ast.b@azhar.edu.eg, 32056_30281_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 11/12/2024 as requested by the trial reviewer. the aproval date is the same as in the aproval letter and is highlighted in orange TRUE, Faculty of Medicine Al Azhar University Assiut, Al Azhar University Assiut, Assiut, 71511, Egypt, , 10 Jan 2021, +2088214803, med.ast.b@azhar.edu.eg, 32056_30281_4737.pdf TRUE, Faculty of Medicine Al Azhar University Assiut, Al Azhar University Assiut, Assiut, 71511, Egypt, , 10 Jan 2021, +2088214803, med.ast.b@azhar.edu.eg, 32056_30281_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 29/12/2024 as requested by the trial reviewer. TRUE, Faculty of Medicine Al Azhar University Assiut, Al Azhar University Assiut, Assiut, 71511, Egypt, , 10 Jan 2021, +2088214803, med.ast.b@azhar.edu.eg, 32056_30281_4737.pdf TRUE, Faculty of Medicine Al Azhar University Assiut, Al Azhar University Assiut, Assiut, 71511, Egypt, , 10 Jan 2021, +2088214803, med.ast.b@azhar.edu.eg, 32056_30281_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 16/01/2025 as requested by the trial reviewer a comprehensive introduction to the fundamental principles and methods that healthcare researchers need when considering, conducting or using individual participant data (IPD) the individual participant data that underlie the results of this study after identification (text, tables, figures) will be 3available on request 12 months after publication of the article. request send to e-mail: elnagarmagdy19@gmail.com
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 22/01/2025 PACTR Admin the individual participant data that underlie the results of this study after identification (text, tables, figures) will be 3available on request 12 months after publication of the article. request send to e-mail: elnagarmagdy19@gmail.com the individual participant data that underlie the results of this study after deidentification (text, tables, figures) will be 3available on request 12 months after publication of the article. request send to e-mail: elnagarmagdy19@gmail.com