Endoscopic Versus Conventional Septoplasty in Treatment of Deviated Nasal Septum

September 10, 2018 updated by: Mostafa Mahrous, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • septoplasty of DNS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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