Septal Extension Graft in RhinoplastyNCT06958575
Outcomes Assessment of Septal Extension Graft Versus Columellar Strut Graft in Rhinoplasty.
A study testing Septal extension graft and Columellar strut in people with Septal Extension Graft in Rhinoplasty, run by Assiut University.
Trial summary
Nose is an important aesthetic landmark with its length, width, shape, and position in the middle of the face. Rhinoplasty is now one of the most common rhinological procedures with both functional and aesthetic aspects. Tip plasty is considered the core of rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septal Extension Graft in Rhinoplasty
- What is being tested?
- Septal extension graft and Columellar strut
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (more than 18 years).
- Patients with any type of tip deformaties.
- Patients fit for surgery.
Who cannot join
- Patients with history of previous nasal surgery.
- Pregnant patients.
- Patients with chronic diseases affecting wound healing e.g. DM and blood diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Nose is an important aesthetic landmark with its length, width, shape, and position in the middle of the face. Rhinoplasty is now one of the most common rhinological procedures with both functional and aesthetic aspects. Tip plasty is considered the core of rhinoplasty. The interaction among lower lateral cartilages, septal cartilage, adjacent soft tissues, tissue dynamics, and surgical techniques determines the nasal tips projection, rotation, and overall shape. Various graft sources and types were used for tip support in rhinoplasty such as columellar struts, septal extensions, and cap grafts.
The columellar strut graft, first introduced in 1932, has became a widely adopted technique. Typically a cartilage graft is positioned between the medial crura to provide support and stability to the nasal tip. Recent studies reported some drawbacks of columellar strut such as widening the columella and resorption or displacement of the graft due to their lack of attachment to the caudal septum. Septal extension grafts extend from the caudal edge of the nasal septum into the lower lateral cartilages, these grafts offer crucial structural support to the nasal tip. Despite of their the wide use of columellar strut and septal extention graft, limited studies compared their results.
- Conditions
- Septal Extension Graft in Rhinoplasty
- Being tested
- Septal extension graft, Columellar strut
- Keywords
- Rhinoplasty, Septal extension graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal extension graftProcedure or surgery
Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal graft.
Columellar strutProcedure or surgery
Columellar strut graft will be used. A strut graft 1012 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal extension grafts. Receives: Procedure: Septal extension graft |
| Group 2 | Active comparator | Columellar strut graft will be used. A strut graft 10-12 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura. Receives: Procedure: Columellar strut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tip projection and rotation
Two factors will be assessed to compare the changes of tip projection and rotation in each group: the ratio of nasal projection to nasal length and the columellar-labial angle values.
The program Rhinobase developed by Apaydin et Al. will be used for photographic analysis to calculate the the ratio of nasal projection to nasal length and the columella labial angle values. This software allowed for consistent and objective measurements that were independent of the individual performing the analysis, minimizing variability. These values will be evaluated before surgical intervention and 6 months after the surgery.
Measured: These values will be evaluated before surgical intervention and 6 months after the surgery
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction will be assessed using an arabic version of validated rhinoplasty outcome evaluation (ROE) questionnaire six months after the surgery. The questionnaire is consist of six questions and each question is scored on 0-4 scale:
0: worest possible outcome. 4:best possible outcome. The score from the six questions are summed up to give the total score. The total is then divided by 24 (the maximum score) and multiplied by 100 to get a percentage.
Measured: Before and 6 months after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septal Extension Graft in RhinoplastyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Aldein Samir Abd Elazeem Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958575
- Sponsor's protocol ID
- septal extension graf
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Assessment of Septal Extension Graft Versus Columellar Strut Graft in Rhinoplasty.
- ClinicalTrials.gov ID
- NCT06958575
- Acronym / sponsor ID
- septal extension graf
- Conditions
- Septal Extension Graft in Rhinoplasty
- Keywords
- Rhinoplasty, Septal extension graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 May 2025 (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.
Nose is an important aesthetic landmark with its length, width, shape, and position in the middle of the face. Rhinoplasty is now one of the most common rhinological procedures with both functional and aesthetic aspects. Tip plasty is considered the core of rhinoplasty. The interaction among lower lateral cartilages, septal cartilage, adjacent soft tissues, tissue dynamics, and surgical techniques determines the nasal tips projection, rotation, and overall shape. Various graft sources and types were used for tip support in rhinoplasty such as columellar struts, septal extensions, and cap grafts.
The columellar strut graft, first introduced in 1932, has became a widely adopted technique. Typically a cartilage graft is positioned between the medial crura to provide support and stability to the nasal tip. Recent studies reported some drawbacks of columellar strut such as widening the columella and resorption or displacement of the graft due to their lack of attachment to the caudal septum. Septal extension grafts extend from the caudal edge of the nasal septum into the lower lateral cartilages, these grafts offer crucial structural support to the nasal tip. Despite of their the wide use of columellar strut and septal extention graft, limited studies compared their results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Septal extension graftSeptal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal extension grafts. |
| Group 2 | Active comparator | Procedure: Columellar strutColumellar strut graft will be used. A strut graft 10-12 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (more than 18 years).
- Patients with any type of tip deformaties.
- Patients fit for surgery.
Key exclusion criteria (3 listed)
- Patients with history of previous nasal surgery.
- Pregnant patients.
- Patients with chronic diseases affecting wound healing e.g. DM and blood diseases.
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 |
|---|---|---|
| Septal extension graftSeptal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal graft. | Procedure or surgery | Group 1 |
| Columellar strutColumellar strut graft will be used. A strut graft 1012 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura. | Procedure or surgery | Group 2 |
Primary outcome
Tip projection and rotation
Time frame: These values will be evaluated before surgical intervention and 6 months after the surgery
Two factors will be assessed to compare the changes of tip projection and rotation in each group: the ratio of nasal projection to nasal length and the columellar-labial angle values. The program Rhinobase developed by Apaydin et Al. will be used for photographic analysis to calculate the the ratio of nasal projection to nasal length and the columella labial angle values. This software allowed for consistent and objective measurements that were independent of the individual performing the analysis, minimizing variability. These values will be evaluated before surgical intervention and 6 months after the surgery.
1 secondary outcome
Patient satisfaction
Time frame: Before and 6 months after the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Septal Extension Graft in Rhinoplasty
Not yet recruiting
Unilateral Septal Extension Graft and Bilateral Septal Extension Graft in Droopy Tip and Its Effect on Tip Deviation
Septal Extension Graft in Rhinoplasty, Primary Rhinoplasty
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.
Questions about this trial
What is this clinical trial studying?
A study testing Septal extension graft and Columellar strut in people with Septal Extension Graft in Rhinoplasty, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam Aldein Mohammed (+201019858519, Hosam.20133977@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tip projection and rotation (time frame: These values will be evaluated before surgical intervention and 6 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.