Cosmetic OutcomePhase 3NCT01907256
Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty
A Phase 3 study testing inverted V incision and stair step incisions in people with Cosmetic Outcome, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cosmetic Outcome
- What is being tested?
- inverted V incision and stair step incisions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- Dec 2012to Nov 2013
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who candidate for open rhinoplasty
Who cannot join
- Revision cases
- History of scar
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty A Randomized Trial
There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.
Read the detailed description
Approaches to rhinoplasty can be separated into two broad categories: external and endonasal, which each of them their own proponent. However, the external approach provide better exposure, critics against this technique is often due to cosmetic deformity regarding the incision. Hence, over the recent years surgeons have modified the trans-columellar incision into two big categories: gull wing and stair steps. While each of them has its own proponents, there is no randomized trial, comparing their cosmetic results.
There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.
- Conditions
- Cosmetic Outcome
- Being tested
- inverted V incision, stair step incisions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inverted V incisionProcedure or surgery
It is a type of incision
stair step incisionsProcedure or surgery
It is a type of incision
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | stair step incisions Receives: Procedure: stair step incisions |
| Group B | Active comparator | inverted V incision Receives: Procedure: inverted V incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hollunder cosmetic score
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery
Measured: one week after surgery,
Hollunder cosmetic score
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery
Measured: one month after surgery
Hollunder cosmetic score
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery
Measured: one year after surgery
Secondary outcomes (3)
Visual analogue score
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery
Measured: one week after surgery,
Visual analogue score
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery
Measured: one month after surgery
Visual analogue score
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic OutcomeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babak Saedi, Tehran University of Medical Sciences
- Investigators
- Babak Saaedi, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907256
- Sponsor's protocol ID
- 92-01-48-20912
- Status last verified
- Jan 2014
- First submitted
- 11 Jul 2013
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty A Randomized Trial
- ClinicalTrials.gov ID
- NCT01907256
- Acronym / sponsor ID
- 92-01-48-20912
- Conditions
- Cosmetic Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.
Detailed description
Approaches to rhinoplasty can be separated into two broad categories: external and endonasal, which each of them their own proponent. However, the external approach provide better exposure, critics against this technique is often due to cosmetic deformity regarding the incision. Hence, over the recent years surgeons have modified the trans-columellar incision into two big categories: gull wing and stair steps. While each of them has its own proponents, there is no randomized trial, comparing their cosmetic results.
There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: stair step incisionsstair step incisions |
| Group B | Active comparator | Procedure: inverted V incisioninverted V incision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who candidate for open rhinoplasty
Key exclusion criteria (3 listed)
- Revision cases
- History of scar
- Systemic 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 |
|---|---|---|
| inverted V incisionIt is a type of incision | Procedure or surgery | Group B |
| stair step incisionsIt is a type of incision | Procedure or surgery | group A |
Primary outcome
Hollunder cosmetic score
Time frame: one week after surgery,
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery
Hollunder cosmetic score
Time frame: one month after surgery
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery
Hollunder cosmetic score
Time frame: one year after surgery
The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery
3 secondary outcomes
Visual analogue score
Time frame: one week after surgery,
Visual analogue score
Time frame: one month after surgery
Visual analogue score
Time frame: one year after surgery
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 20 Jan 2014.
Related trials for Cosmetic Outcome
Not yet recruiting
Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
Breast Fibroadenoma
RecruitingPhase 3
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Breast Neoplasm Female, Radiotherapy
Active, not recruitingObservational study
SMC Radiation Oncology Breast Cancer Cohort Study
Radiotherapy Side Effect
RecruitingPhase 2
Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial
Recurrent Breast Carcinoma, Ipsilateral Recurrence
Recruiting
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Breast Cancer
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.
Babak Saaedi principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing inverted V incision and stair step incisions in people with Cosmetic Outcome, run by Tehran University of Medical Sciences at 1 site in Iran.
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 20 Jan 2014. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hollunder cosmetic score (time frame: one week after surgery,). The study lists 3 primary outcomes in all. 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 20 Jan 2014.