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Endoscopic Versus Conventional Septoplasty in Treatment of Deviated Nasal Septum

A

Assiut University

Status

Unknown

Conditions

Endoscopic Septoplasty

Treatments

Procedure: endoscopic septoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03666130
septoplasty of DNS

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

endoscopic septoplasty
Active Comparator group
Description:
in this arm the participants will undergo endoscopic septoplasty for correction of the deviated nasal septum
Treatment:
Procedure: endoscopic septoplasty
conventional septoplasty
Active Comparator group
Description:
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
Treatment:
Procedure: endoscopic septoplasty

Trial contacts and locations

0

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Central trial contact

mostafa m mahmoud, ba; mohamed o gad, Ph.D.

Data sourced from clinicaltrials.gov

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