Endoscopic SeptoplastyNCT03666130
Endoscopic Versus Conventional Septoplasty in Treatment of Deviated Nasal Septum
A study testing endoscopic septoplasty in people with Endoscopic Septoplasty, run by Assiut University.
Trial summary
This study aims to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation and /or other postoperative complications following each techniques of surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endoscopic Septoplasty
- What is being tested?
- endoscopic 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
- 1 Nov 2018to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with deviated nasal septum with persistent symptoms for at least 3 months and had not responded to maximal medical management.
- patients of deviated nasal septum cased by either childbirth trauma or recent
Who cannot join
- patients of asymptomatic deviated nasal septum
- patients who had a history of previous nasal surgery
- patients who had other causes of nasal obstruction
- patients who had received radiotherapy of head and neck region.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endoscopic Versus Conventional Septoplasty in the Treatment of Deviated Nasal Septum
This study aims to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation and /or other postoperative complications following each techniques of surgery.
Read the detailed description
A straight septum is found not to be the dominant but the exception.
A deviated septum can be asymptomatic or can cause functional and cosmetic abnormality. it also can become symptomatic at any age. Deviated nasal septum not only causes breathing difficulties but also causes improper aeration of para nasal sinuses leading to infection, so any functional or cosmetic disturbance caused by a deviated septum should be treated. Different surgeries have been proposed for the correction of deviated nasal septum. Initially, submucosal resection of septum was proposed but was later replaced by septoplasty .
Septoplasty is the procedure of choice in nasal obstruction caused by septal deviation resistant to medical treatment. It also improves access to the medial meatus in sinus surgery and other nasal and sinus procedures, such as cosmetic rhinoplasty and functional endoscopic sinus surgery(FESS)
Modern septoplasty techniques were initially described separately in the early twenties century by Killian and Freer. It is conventionally performed under direct visualization using a headlight and nasal speculum. However, this method has the drawbacks of relatively poor illumination and accessibility and no magnification, calling for a larger incision and elevation of larger flaps often on both sides of the septum. As a result, there are higher chances of over-resection and over manipulation. Endoscopic septoplasty has been commonly performed since the development of endonasal surgery and as as an alternative to the conventional technique. In this study the I investigators aim to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation following each techniques of surgery.
- Conditions
- Endoscopic Septoplasty
- Being tested
- endoscopic 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 septoplasty is the use of nasal endoscopy in the septoplasty surgery for treatment of deviated nasal septum . we aim to compare the outcome of using this method versus conventional septoplasty
| Study group | Role | What they receive |
|---|---|---|
| endoscopic septoplasty | Active comparator | in this arm the participants will undergo endoscopic septoplasty for correction of the deviated nasal septum Receives: Procedure: endoscopic septoplasty |
| conventional septoplasty | Active comparator | in this arm the participants will undergo conventional septoplasty operation for correction of the deviated nasal septum that will done by surgical traditional septoplasty technique using head lamb and anterior rhinoscopy Receives: Procedure: endoscopic septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients free from symptoms after surgery
the relive of the nasal obstruction symptoms as difficult breathing and nasal discharge and the complication of each method of surgery as synechia formation and postoperative bleeding
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Nov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endoscopic SeptoplastyStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahrous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666130
- Sponsor's protocol ID
- septoplasty of DNS
- Status last verified
- Sep 2018
- First submitted
- 30 Jul 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clark DW, Del Signore AG, Raithatha R, Senior BA. Nasal airway obstruction: Prevalence and anatomic contributors. Ear Nose Throat J. 2018 Jun;97(6):173-176. doi: 10.1177/014556131809700615.
PubMed 30036414Chandra RK. Endoscopic septoplasty: "How I do it". Am J Rhinol Allergy. 2017 Jul 1;31(4):276-277. doi: 10.2500/ajra.2017.31.4436.
PubMed 28716180Hong CJ, Monteiro E, Badhiwala J, Lee J, de Almeida JR, Vescan A, Witterick IJ. Open versus endoscopic septoplasty techniques: A systematic review and meta-analysis. Am J Rhinol Allergy. 2016 Nov 1;30(6):436-442. doi: 10.2500/ajra.2016.30.4366.
PubMed 28124656Shah J, Roxbury CR, Sindwani R. Techniques in Septoplasty: Traditional Versus Endoscopic Approaches. Otolaryngol Clin North Am. 2018 Oct;51(5):909-917. doi: 10.1016/j.otc.2018.05.007. Epub 2018 Jul 17.
PubMed 30025848Sathyaki DC, Geetha C, Munishwara GB, Mohan M, Manjuanth K. A comparative study of endoscopic septoplasty versus conventional septoplasty. Indian J Otolaryngol Head Neck Surg. 2014 Jun;66(2):155-61. doi: 10.1007/s12070-013-0692-0. Epub 2013 Nov 24.
PubMed 24822154Skitarelic NB, Vukovic K, Skitarelic NP. Comparative evaluation of conventional versus endoscopic septoplasty for limited septal deviation and spur. J Laryngol Otol. 2009 Aug;123(8):939-40; author reply 940. doi: 10.1017/S0022215109005556. Epub 2009 May 27. No abstract available.
PubMed 19470189Atan D, Ozcan KM, Gurbuz AB, Dere H. The Effect of Septoplasty on Voice Performance in Patients With Severe and Mild Nasal Septal Deviation. J Craniofac Surg. 2016 Jul;27(5):1162-4. doi: 10.1097/SCS.0000000000002794.
PubMed 27380579Champagne C, Ballivet de Regloix S, Genestier L, Crambert A, Maurin O, Pons Y. Endoscopic vs. conventional septoplasty: A review of the literature. Eur Ann Otorhinolaryngol Head Neck Dis. 2016 Feb;133(1):43-6. doi: 10.1016/j.anorl.2015.11.004. Epub 2015 Dec 8.
PubMed 26679230
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Versus Conventional Septoplasty in the Treatment of Deviated Nasal Septum
- ClinicalTrials.gov ID
- NCT03666130
- Acronym / sponsor ID
- septoplasty of DNS
- Conditions
- Endoscopic Septoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Sep 2018 (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.
This study aims to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation and /or other postoperative complications following each techniques of surgery.
Detailed description
A straight septum is found not to be the dominant but the exception.
A deviated septum can be asymptomatic or can cause functional and cosmetic abnormality. it also can become symptomatic at any age. Deviated nasal septum not only causes breathing difficulties but also causes improper aeration of para nasal sinuses leading to infection, so any functional or cosmetic disturbance caused by a deviated septum should be treated. Different surgeries have been proposed for the correction of deviated nasal septum. Initially, submucosal resection of septum was proposed but was later replaced by septoplasty .
Septoplasty is the procedure of choice in nasal obstruction caused by septal deviation resistant to medical treatment. It also improves access to the medial meatus in sinus surgery and other nasal and sinus procedures, such as cosmetic rhinoplasty and functional endoscopic sinus surgery(FESS)
Modern septoplasty techniques were initially described separately in the early twenties century by Killian and Freer. It is conventionally performed under direct visualization using a headlight and nasal speculum. However, this method has the drawbacks of relatively poor illumination and accessibility and no magnification, calling for a larger incision and elevation of larger flaps often on both sides of the septum. As a result, there are higher chances of over-resection and over manipulation. Endoscopic septoplasty has been commonly performed since the development of endonasal surgery and as as an alternative to the conventional technique. In this study the I investigators aim to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation following each techniques of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic septoplasty | Active comparator | Procedure: endoscopic septoplastyin this arm the participants will undergo endoscopic septoplasty for correction of the deviated nasal septum |
| conventional septoplasty | Active comparator | Procedure: endoscopic septoplastyin this arm the participants will undergo conventional septoplasty operation for correction of the deviated nasal septum that will done by surgical traditional septoplasty technique using head lamb and anterior rhinoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with deviated nasal septum with persistent symptoms for at least 3 months and had not responded to maximal medical management.
- patients of deviated nasal septum cased by either childbirth trauma or recent
Key exclusion criteria (4 listed)
- patients of asymptomatic deviated nasal septum
- patients who had a history of previous nasal surgery
- patients who had other causes of nasal obstruction
- patients who had received radiotherapy of head and neck region.
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 septoplasty is the use of nasal endoscopy in the septoplasty surgery for treatment of deviated nasal septum . we aim to compare the outcome of using this method versus conventional septoplasty | Procedure or surgery | conventional septoplasty, endoscopic septoplasty |
Primary outcome
The percentage of patients free from symptoms after surgery
Time frame: 3 months
the relive of the nasal obstruction symptoms as difficult breathing and nasal discharge and the complication of each method of surgery as synechia formation and postoperative bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Results publication: PubMed 30036414Clark DW, Del Signore AG, Raithatha R, Senior BA. Nasal airway obstruction: Prevalence and anatomic contributors. Ear Nose Throat J. 2018 Jun;97(6):173-176. doi: 10.1177/014556131809700615.
- Results publication: PubMed 28716180Chandra RK. Endoscopic septoplasty: "How I do it". Am J Rhinol Allergy. 2017 Jul 1;31(4):276-277. doi: 10.2500/ajra.2017.31.4436.
- Results publication: PubMed 28124656Hong CJ, Monteiro E, Badhiwala J, Lee J, de Almeida JR, Vescan A, Witterick IJ. Open versus endoscopic septoplasty techniques: A systematic review and meta-analysis. Am J Rhinol Allergy. 2016 Nov 1;30(6):436-442. doi: 10.2500/ajra.2016.30.4366.
- Results publication: PubMed 30025848Shah J, Roxbury CR, Sindwani R. Techniques in Septoplasty: Traditional Versus Endoscopic Approaches. Otolaryngol Clin North Am. 2018 Oct;51(5):909-917. doi: 10.1016/j.otc.2018.05.007. Epub 2018 Jul 17.
- Results publication: PubMed 24822154Sathyaki DC, Geetha C, Munishwara GB, Mohan M, Manjuanth K. A comparative study of endoscopic septoplasty versus conventional septoplasty. Indian J Otolaryngol Head Neck Surg. 2014 Jun;66(2):155-61. doi: 10.1007/s12070-013-0692-0. Epub 2013 Nov 24.
- Results publication: PubMed 19470189Skitarelic NB, Vukovic K, Skitarelic NP. Comparative evaluation of conventional versus endoscopic septoplasty for limited septal deviation and spur. J Laryngol Otol. 2009 Aug;123(8):939-40; author reply 940. doi: 10.1017/S0022215109005556. Epub 2009 May 27. No abstract available.
- Results publication: PubMed 27380579Atan D, Ozcan KM, Gurbuz AB, Dere H. The Effect of Septoplasty on Voice Performance in Patients With Severe and Mild Nasal Septal Deviation. J Craniofac Surg. 2016 Jul;27(5):1162-4. doi: 10.1097/SCS.0000000000002794.
- Results publication: PubMed 26679230Champagne C, Ballivet de Regloix S, Genestier L, Crambert A, Maurin O, Pons Y. Endoscopic vs. conventional septoplasty: A review of the literature. Eur Ann Otorhinolaryngol Head Neck Dis. 2016 Feb;133(1):43-6. doi: 10.1016/j.anorl.2015.11.004. Epub 2015 Dec 8.
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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 in people with Endoscopic Septoplasty, 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 2 inclusion and 4 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 11 Sep 2018. 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 mostafa m mahmoud, ba (+201061877662, mostafamahrouss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients free from symptoms after surgery (time frame: 3 months). 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 NCT03666130, which also lists 8 linked publications.
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 11 Sep 2018.