Intranasal SurgeryNCT02653950
Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum
A study testing Endoscopic septoplasty and Traditional septoplasty in people with Intranasal Surgery, run by Rambam Health Care Campus.
Trial summary
In this study the investigators aim to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications. Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intranasal Surgery
- What is being tested?
- Endoscopic septoplasty and Traditional septoplasty
- 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
- Feb 2016to Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
- Patient undergoing surgery for repairing the deviated nasal septum.
Who cannot join
- Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
- Patients undergoing endoscopic sinonasal surgery.
- Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
- Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
- Patients listed for revision surgery
- Neoplasms - untreated or under active or recent treatment with chemotherapy or radiotherapy
- Unable to give informed consent due to mental impairment
- Unable to adhere follow up or treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial
In this study the investigators aim to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary outcomes:
- To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
- To evaluate the differences in the operation time between the two different approaches.
Read the detailed description
Nasal obstruction is one of the most common complaints that the otorhinolaryngologist faces in the daily practice. Deviated nasal septum (DNS) is a very frequently encountered and common cause. It not only causes breathing difficulties but also results in improper aeration of paranasal sinuses predisiposing to sinusitis and also results in drying of mucosa leading to crusting and epistaxis 1,2. DNS can also be accompanied with hypertrophic nasal turbinates causing sleep disturbances and snoring3.
Septoplasty is an accepted and common surgical intervention to improve the nasal airway4 and sleep disturbances3.
Traditional septoplasty procedure involves sum mucosal resection of the anterior septum. The results for long-term symptom relief after traditional septoplasty are contradictory in reviewed publications 5.
In the last two decades the endoscopic Sino nasal surgery has been widely used including endoscopic approach for septoplasty. Endoscopic septoplasty as a minimally invasive technique where the dissection of the nasal septal flap can be limited minimizing trauma. The excellent visualization is presumed to decrease morbidity and post-operative swelling in isolated septal deviation by limiting the excision to the area of deviation 2. Furthermore, diagnosing and treating abnormalities of the lateral wall of the nose at the same sitting is only feasible in the endoscopic approach.
At the time of this study, there are no studies comparing the changes of quality of life in patients undergoing traditional septoplasty Vs endoscopic septoplasty.
The investigators aimed to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Aims
Primary:
- To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary:
- To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
- To evaluate the differences in the operation time between the two different approaches.
- Conditions
- Intranasal Surgery
- Being tested
- Endoscopic septoplasty, Traditional septoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic septoplastyProcedure or surgery
Endoscopic surgery; septoplasty with or without middle turbenectomy
Traditional septoplastyProcedure or surgery
septoplasty under direct vision
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | a control arm of patients undergoing traditional septoplasty for DNS Receives: Procedure: Traditional septoplasty |
| Endoscopic | Experimental | patients undergoing endoscopic septoplasty. Receives: Procedure: Endoscopic septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life
quality of life will assessed using Sino-Nasal Outcome Test-22 (SNOT-22) scores.
Measured: Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 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 posted13 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019 (estimated)
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 Intranasal SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHOROOK NA'ARA MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653950
- Sponsor's protocol ID
- 0576-15-RMB
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 13 Jan 2016
- Results posted
- No
Publications
Na'ara S, Kaptzan B, Gil Z, Ostrovsky D. Endoscopic Septoplasty Versus Traditional Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial. Ear Nose Throat J. 2021 Nov;100(9):673-678. doi: 10.1177/0145561320918982. Epub 2020 Apr 27.
PubMed 32339048
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02653950
- Acronym / sponsor ID
- 0576-15-RMB
- Conditions
- Intranasal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2019 (estimated)
- First posted
- 13 Jan 2016 (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.
In this study the investigators aim to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary outcomes:
- To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
- To evaluate the differences in the operation time between the two different approaches.
Detailed description
Nasal obstruction is one of the most common complaints that the otorhinolaryngologist faces in the daily practice. Deviated nasal septum (DNS) is a very frequently encountered and common cause. It not only causes breathing difficulties but also results in improper aeration of paranasal sinuses predisiposing to sinusitis and also results in drying of mucosa leading to crusting and epistaxis 1,2. DNS can also be accompanied with hypertrophic nasal turbinates causing sleep disturbances and snoring3.
Septoplasty is an accepted and common surgical intervention to improve the nasal airway4 and sleep disturbances3.
Traditional septoplasty procedure involves sum mucosal resection of the anterior septum. The results for long-term symptom relief after traditional septoplasty are contradictory in reviewed publications 5.
In the last two decades the endoscopic Sino nasal surgery has been widely used including endoscopic approach for septoplasty. Endoscopic septoplasty as a minimally invasive technique where the dissection of the nasal septal flap can be limited minimizing trauma. The excellent visualization is presumed to decrease morbidity and post-operative swelling in isolated septal deviation by limiting the excision to the area of deviation 2. Furthermore, diagnosing and treating abnormalities of the lateral wall of the nose at the same sitting is only feasible in the endoscopic approach.
At the time of this study, there are no studies comparing the changes of quality of life in patients undergoing traditional septoplasty Vs endoscopic septoplasty.
The investigators aimed to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Aims
Primary:
- To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary:
- To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
- To evaluate the differences in the operation time between the two different approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Procedure: Traditional septoplastya control arm of patients undergoing traditional septoplasty for DNS |
| Endoscopic | Experimental | Procedure: Endoscopic septoplastypatients undergoing endoscopic septoplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
- Patient undergoing surgery for repairing the deviated nasal septum.
Key exclusion criteria (8 listed)
- Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
- Patients undergoing endoscopic sinonasal surgery.
- Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
- Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
- Patients listed for revision surgery
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 |
|---|---|---|
| Endoscopic septoplastyEndoscopic surgery; septoplasty with or without middle turbenectomy | Procedure or surgery | Endoscopic |
| Traditional septoplastyseptoplasty under direct vision | Procedure or surgery | Traditional |
Primary outcome
Change in Quality of life
Time frame: Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.
quality of life will assessed using Sino-Nasal Outcome Test-22 (SNOT-22) scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 32339048Na'ara S, Kaptzan B, Gil Z, Ostrovsky D. Endoscopic Septoplasty Versus Traditional Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial. Ear Nose Throat J. 2021 Nov;100(9):673-678. doi: 10.1177/0145561320918982. Epub 2020 Apr 27.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic septoplasty and Traditional septoplasty in people with Intranasal Surgery, run by Rambam Health Care Campus.
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 8 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 13 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shorook Na'ara, MD (00972507977510, shorook.n@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life (time frame: Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.). 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 NCT02653950, 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 13 Jan 2016.