Endoscopic Versus Conventional Septoplasty in Treatment of Deviated Nasal Septum

NCT ID: NCT03666130

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Endoscopic Septoplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endoscopic septoplasty

in this arm the participants will undergo endoscopic septoplasty for correction of the deviated nasal septum

Group Type ACTIVE_COMPARATOR

endoscopic septoplasty

Intervention Type PROCEDURE

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

conventional septoplasty

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

Group Type ACTIVE_COMPARATOR

endoscopic septoplasty

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endoscopic septoplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

1. patients of asymptomatic deviated nasal septum
2. patients who had a history of previous nasal surgery
3. patients who had other causes of nasal obstruction
4. patients who had received radiotherapy of head and neck region.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mostafa Mahrous

Institutional Review Board (IRB) of faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

mostafa m mahmoud, ba

Role: CONTACT

+201061877662

mohamed o gad, Ph.D.

Role: CONTACT

+201227006258

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 30036414 (View on PubMed)

Chandra 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.

Reference Type RESULT
PMID: 28716180 (View on PubMed)

Hong 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.

Reference Type RESULT
PMID: 28124656 (View on PubMed)

Shah 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.

Reference Type RESULT
PMID: 30025848 (View on PubMed)

Sathyaki 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.

Reference Type RESULT
PMID: 24822154 (View on PubMed)

Skitarelic 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.

Reference Type RESULT
PMID: 19470189 (View on PubMed)

Atan 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.

Reference Type RESULT
PMID: 27380579 (View on PubMed)

Champagne 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.

Reference Type RESULT
PMID: 26679230 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

septoplasty of DNS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.