Surgical Procedure, UnspecifiedNCT01883687
Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
A study testing Septoplasty in people with Surgical Procedure, Unspecified, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery with Le Fort I osteotomy, and (3) to explore… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Septoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2013to Apr 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Taiwanese adults with dentofacial deformities (DFD)
- Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation
- Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013
Who cannot join
- Previous OGS or nasal surgery
- Patients with nasal polyposis, rhinosinusitis or neoplasia
- Patients with clefts or craniofacial anomaly
- Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use
- Noncompliance for test
- Noncompliance to test schedule
- Won't sign informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital
Taoyuan
Yu-Fang Liao, PHD, +886-3-3196200 ext. 3500
Yu-Fang Liao, PHD
About this study
Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal surgery may reduce nasal obstruction severity.
Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with unilateral cleft lip and palate and dentofacial deformity (age >16 for females, >18 for males; 40 in experimental and 40 in control groups) Interventions: In the experimental group, all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all patients will receive Le Fort I osteotomy only.
Read more
Measurements: All patients will undergo history taking, clinical examination, radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and 24 months after surgery.
Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a p value of less than 0.05.
Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty, effectiveness
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Septoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeptoplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Septoplasty | Experimental | patients will receive septoplasty together with Le Fort I osteotomy Receives: Procedure: Septoplasty |
| No septoplasty | No intervention | patient will only receive Le Fort I osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in symptom severity and health-related quality of life in sinonasal conditions
Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used
Measured: before surgery and 24 months after surgery
Secondary outcomes (4)
Changes in nasal patency and congestion
Acoustic rhinometry will be used
Measured: before surgery and 24 months after surgery
Changes of nasal airway volume
Measured: before surgery and 24 months after surgery
Changes in transnasal pressure and airway resistance and pressure-flow characteristics
Rhinomanometry will be used
Measured: before surgery and 24 months after surgery
Changes of causative allergens
RAST examination will be used
Measured: before surgery and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Fang Liao, PHD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883687
- Sponsor's protocol ID
- 102-0546C
- Status last verified
- Apr 2013
- First submitted
- 23 May 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
- ClinicalTrials.gov ID
- NCT01883687
- Acronym / sponsor ID
- 102-0546C
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 21 Jun 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.
Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal surgery may reduce nasal obstruction severity.
Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with unilateral cleft lip and palate and dentofacial deformity (age >16 for females, >18 for males; 40 in experimental and 40 in control groups) Interventions: In the experimental group, all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all patients will receive Le Fort I osteotomy only.
Measurements: All patients will undergo history taking, clinical examination, radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and 24 months after surgery.
Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a p value of less than 0.05.
Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty, effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septoplasty | Experimental | Procedure: Septoplastypatients will receive septoplasty together with Le Fort I osteotomy |
| No septoplasty | No intervention | –patient will only receive Le Fort I osteotomy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Taiwanese adults with dentofacial deformities (DFD)
- Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation
- Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013
Key exclusion criteria (7 listed)
- Previous OGS or nasal surgery
- Patients with nasal polyposis, rhinosinusitis or neoplasia
- Patients with clefts or craniofacial anomaly
- Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use
- Noncompliance for test
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 |
|---|---|---|
| Septoplasty | Procedure or surgery | Septoplasty |
Primary outcome
Changes in symptom severity and health-related quality of life in sinonasal conditions
Time frame: before surgery and 24 months after surgery
Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used
4 secondary outcomes
Changes in nasal patency and congestion
Time frame: before surgery and 24 months after surgery
Changes of nasal airway volume
Time frame: before surgery and 24 months after surgery
Changes in transnasal pressure and airway resistance and pressure-flow characteristics
Time frame: before surgery and 24 months after surgery
Changes of causative allergens
Time frame: before surgery and 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 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.
Yu-Fang Liao, PHD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septoplasty in people with Surgical Procedure, Unspecified, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Fang Liao, PHD (+886-3-3196200 ext. 3500, yufang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in symptom severity and health-related quality of life in sinonasal conditions (time frame: before surgery and 24 months after 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 21 Jun 2013.