Endoscopic Versus Conventional Septoplasty in Treatment of Deviated Nasal Septum

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03666130
Collaborator
(none)
60
2
13

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoscopic septoplasty
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endoscopic Versus Conventional Septoplasty in the Treatment of Deviated Nasal Septum
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: endoscopic septoplasty

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

Procedure: 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

Active Comparator: 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

Procedure: 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

Outcome Measures

Primary Outcome Measures

  1. The percentage of patients free from symptoms after surgery [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mostafa Mahrous, Institutional Review Board (IRB) of faculty of medicine, Assiut University
ClinicalTrials.gov Identifier:
NCT03666130
Other Study ID Numbers:
  • septoplasty of DNS
First Posted:
Sep 11, 2018
Last Update Posted:
Sep 11, 2018
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 11, 2018