Rhinoplasty TechniquesPhase 2/3NCT01852643
Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty
A Phase 2/3 study testing Spreader graft and Lateral crural overlay in people with Rhinoplasty Techniques, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoplasty Techniques
- What is being tested?
- Spreader graft and Lateral crural overlay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 2/3
- 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
- Candidates of rhinoplasty
- Willingness to participate
Who cannot join
- Having structural problems such as nasal obstruction
- History of the deformity requiring rhinoplasty of the deviated septum
- Hardening surgery
- New clinical conditions or a change in therapeutic technique
- Unwillingness to continue participating in the study
- Having no access to subjects after the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determine and Compare the Finding of Rhinomanometry Before and After Treatment in Two Ways of Rhinoplasty Surgery (Spreader Graft and Lateral Crural Over Lapping)
Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Therefore, in this study the investigators are going to compare the efficacy of spreader graft and lateral crural overlay techniques by an objective method, rhinomanometry.
- Conditions
- Rhinoplasty Techniques
- Being tested
- Spreader graft, Lateral crural overlay
- Keywords
- Rhinoplasty, Spreader graft technique, Lateral crural overlay technique, Rhinomanometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spreader graftProcedure or surgery
Spreader graft technique is performed by a group of expert surgeons.
Lateral crural overlayProcedure or surgery
Lateral crural overlay technique is performed by a group of expert surgeons.
| Study group | Role | What they receive |
|---|---|---|
| Spreader graft | Active comparator | Not described Receives: Procedure: Spreader graft |
| Lateral crural overlay | Active comparator | Not described Receives: Procedure: Lateral crural overlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal flow
Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).
Measured: Up to 3 months
Nasal resistance
Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinoplasty TechniquesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amiryousef Ahmadnia, Isfahan University of Medical Sciences
- Investigators
- Amiryousef Ahmadnia, MD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852643
- Sponsor's protocol ID
- 390548
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine and Compare the Finding of Rhinomanometry Before and After Treatment in Two Ways of Rhinoplasty Surgery (Spreader Graft and Lateral Crural Over Lapping)
- ClinicalTrials.gov ID
- NCT01852643
- Acronym / sponsor ID
- 390548
- Conditions
- Rhinoplasty Techniques
- Keywords
- Rhinoplasty, Spreader graft technique, Lateral crural overlay technique, Rhinomanometry
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 May 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.
Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Therefore, in this study the investigators are going to compare the efficacy of spreader graft and lateral crural overlay techniques by an objective method, rhinomanometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spreader graft | Active comparator | Procedure: Spreader graft |
| Lateral crural overlay | Active comparator | Procedure: Lateral crural overlay |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates of rhinoplasty
- Willingness to participate
Key exclusion criteria (6 listed)
- Having structural problems such as nasal obstruction
- History of the deformity requiring rhinoplasty of the deviated septum
- Hardening surgery
- New clinical conditions or a change in therapeutic technique
- Unwillingness to continue participating in the study
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 |
|---|---|---|
| Spreader graftSpreader graft technique is performed by a group of expert surgeons. | Procedure or surgery | Spreader graft |
| Lateral crural overlayLateral crural overlay technique is performed by a group of expert surgeons. | Procedure or surgery | Lateral crural overlay |
Primary outcome
Nasal flow
Time frame: Up to 3 months
Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).
Nasal resistance
Time frame: Up to 3 months
Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).
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 14 May 2013.
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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.
Amiryousef Ahmadnia, MD principal investigator
Isfahan 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 2/3 study testing Spreader graft and Lateral crural overlay in people with Rhinoplasty Techniques, run by Isfahan 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 2 inclusion and 6 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 14 May 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Nasal flow (time frame: Up to 3 months). 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?
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 14 May 2013.