RhinoplastyNCT06370455
Comparison of Septal Advancement Flap and Columellar Strut Effect on Nasal Tip
A study testing comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique in people with Rhinoplasty, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty
- What is being tested?
- comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2024to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Droopy nasal tip
Who cannot join
- severely deficient cartilaginous septum.
- previous nasal operations, history of cleft lip or cleft palate.
- bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Septal Advancement Flap and Columellar Strut in Preserving, Restructuring, and Reshaping the Nasal Tip Contour in Rhinoplasty
The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft
Read the detailed description
The ideal tip support graft should support the exact position over time, avoid stiffness of a natural soft structure of the tip, be easily harvested typically septal cartilage, facilitate surgeon control of rotation and projection.
To address these desirable features the septal advancement flap (SAF) was developed. The septal advancement flap (SAF) is a rotational advancement flap of the superior and caudal aspects of the cartilaginous septum that enables the surgeon to create stable and accurate tip shape and position. This is a technically easy and reliable flap mainly applicable to primary rhinoplasty.
so investigator compare between this new technique and old one like columellar strut to know the effect on nasal tip
- Conditions
- Rhinoplasty
- Being tested
- comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut techniqueProcedure or surgery
All patients will be operated on under general anesthesia through an open rhinoplasty then will undergo 2 different procedures according to each group.
| Study group | Role | What they receive |
|---|---|---|
| Septal advancement flap group | Active comparator | Fifteen patients will undergo septal advancement flap technique The mucoperichondrial flaps are elevated over the cartilaginous septum and the caudal perpendicular plate of the ethmoid. investigator will take L shape flap of the dorsal and anterior end of cartilaginous septum then advance them and suture the flap at certain points so can support the nasal tip. Receives: Procedure: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique |
| Columellar strut group | Active comparator | fifteen patients will undergo columellar strut technique. investigator will extract columellar strut from septal cartilage then insert it between the two medial crura n the intercrural space and sutured to nasal spine so can support nasal tip. Receives: Procedure: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire
Assessment of patient satisfaction with primary septorhinoplasty using the Arabic Rhinoplasty Outcome Evaluation (ROE) Questionnaire and comparing the preoperative with postoperative scores. The ROE comprises 6 questions. Each answer is scored on a scale from 0-4, where 0 corresponds to the "most negative answer" and 4 corresponds to the "most positive answer." As a result, the total score can range from 0 to 24.
To make the results easier to understand, the total score can be divided by 24 and multiplied by 100 to obtain a value between 0% and 100%, where higher values represent greater patient satisfaction.
Measured: preoperative and one month postoperative
measuring the degree of tip projection and rotation preoperative and postoperative
Objective assessment by measuring the degree of tip projection and rotation preoperative and postoperative by using the angle between the columella and the line intersecting the junction between the columella and the upper lip and the vermilion border of the upper lip for measuring the nasolabial angle.
Measured: Preoperative,one month and six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start23 Jan 2024
- Primary completion23 Aug 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaied Allam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370455
- Sponsor's protocol ID
- 36264MS429/11/23
- Status last verified
- Aug 2025
- First submitted
- 12 Apr 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goncalves Ferreira M. Septal Advancement Flap: Preserving, Restructuring, and Reshaping the Nasal Tip Contour with a Novel Flap. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):279-284. doi: 10.1089/fpsam.2023.0060. Epub 2023 Apr 10.
PubMed 37036815
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Septal Advancement Flap and Columellar Strut in Preserving, Restructuring, and Reshaping the Nasal Tip Contour in Rhinoplasty
- ClinicalTrials.gov ID
- NCT06370455
- Acronym / sponsor ID
- 36264MS429/11/23
- Conditions
- Rhinoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft
Detailed description
The ideal tip support graft should support the exact position over time, avoid stiffness of a natural soft structure of the tip, be easily harvested typically septal cartilage, facilitate surgeon control of rotation and projection.
To address these desirable features the septal advancement flap (SAF) was developed. The septal advancement flap (SAF) is a rotational advancement flap of the superior and caudal aspects of the cartilaginous septum that enables the surgeon to create stable and accurate tip shape and position. This is a technically easy and reliable flap mainly applicable to primary rhinoplasty.
so investigator compare between this new technique and old one like columellar strut to know the effect on nasal tip
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septal advancement flap group | Active comparator | Procedure: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut techniqueFifteen patients will undergo septal advancement flap technique The mucoperichondrial flaps are elevated over the cartilaginous septum and the caudal perpendicular plate of the ethmoid. investigator will take L shape flap of the dorsal and anterior end of cartilaginous septum then advance them and suture the flap at certain points so can support the nasal tip. |
| Columellar strut group | Active comparator | Procedure: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut techniquefifteen patients will undergo columellar strut technique. investigator will extract columellar strut from septal cartilage then insert it between the two medial crura n the intercrural space and sutured to nasal spine so can support nasal tip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Droopy nasal tip
Key exclusion criteria (3 listed)
- severely deficient cartilaginous septum.
- previous nasal operations, history of cleft lip or cleft palate.
- bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut techniqueAll patients will be operated on under general anesthesia through an open rhinoplasty then will undergo 2 different procedures according to each group. | Procedure or surgery | Columellar strut group, Septal advancement flap group |
Primary outcome
subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire
Time frame: preoperative and one month postoperative
Assessment of patient satisfaction with primary septorhinoplasty using the Arabic Rhinoplasty Outcome Evaluation (ROE) Questionnaire and comparing the preoperative with postoperative scores. The ROE comprises 6 questions. Each answer is scored on a scale from 0-4, where 0 corresponds to the "most negative answer" and 4 corresponds to the "most positive answer." As a result, the total score can range from 0 to 24. To make the results easier to understand, the total score can be divided by 24 and multiplied by 100 to obtain a value between 0% and 100%, where higher values represent greater patient satisfaction.
measuring the degree of tip projection and rotation preoperative and postoperative
Time frame: Preoperative,one month and six months postoperative
Objective assessment by measuring the degree of tip projection and rotation preoperative and postoperative by using the angle between the columella and the line intersecting the junction between the columella and the upper lip and the vermilion border of the upper lip for measuring the nasolabial angle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 37036815Goncalves Ferreira M. Septal Advancement Flap: Preserving, Restructuring, and Reshaping the Nasal Tip Contour with a Novel Flap. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):279-284. doi: 10.1089/fpsam.2023.0060. Epub 2023 Apr 10.
Related trials for Rhinoplasty
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Enrolling by invitationObservational study
Screen Addiction and Postoperative Pain
Pain, Postoperative
Active, not recruitingPhase 1
A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty
Pain, Postoperative, Opioid Use
RecruitingPhase 2
Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
Pain, Postoperative
Active, not recruiting
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
Rhinoplasty Techniques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique in people with Rhinoplasty, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire (time frame: preoperative and one month postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.