Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-03-15 @ 3:29 AM
Study NCT ID:
NCT02653950
Status:
UNKNOWN
Last Update Posted:
2016-01-13
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators aim to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary outcomes:
1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
2. To evaluate the differences in the operation time between the two different approaches.
Primary outcome: To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary outcomes:
1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
2. To evaluate the differences in the operation time between the two different approaches.
Detailed Description:
Nasal obstruction is one of the most common complaints that the otorhinolaryngologist faces in the daily practice. Deviated nasal septum (DNS) is a very frequently encountered and common cause. It not only causes breathing difficulties but also results in improper aeration of paranasal sinuses predisiposing to sinusitis and also results in drying of mucosa leading to crusting and epistaxis 1,2. DNS can also be accompanied with hypertrophic nasal turbinates causing sleep disturbances and snoring3.
Septoplasty is an accepted and common surgical intervention to improve the nasal airway4 and sleep disturbances3.
Traditional septoplasty procedure involves sum mucosal resection of the anterior septum. The results for long-term symptom relief after traditional septoplasty are contradictory in reviewed publications 5.
In the last two decades the endoscopic Sino nasal surgery has been widely used including endoscopic approach for septoplasty. Endoscopic septoplasty as a minimally invasive technique where the dissection of the nasal septal flap can be limited minimizing trauma. The excellent visualization is presumed to decrease morbidity and post-operative swelling in isolated septal deviation by limiting the excision to the area of deviation 2. Furthermore, diagnosing and treating abnormalities of the lateral wall of the nose at the same sitting is only feasible in the endoscopic approach.
At the time of this study, there are no studies comparing the changes of quality of life in patients undergoing traditional septoplasty Vs endoscopic septoplasty.
The investigators aimed to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Aims
Primary:
1\) To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary:
1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
2. To evaluate the differences in the operation time between the two different approaches.
Septoplasty is an accepted and common surgical intervention to improve the nasal airway4 and sleep disturbances3.
Traditional septoplasty procedure involves sum mucosal resection of the anterior septum. The results for long-term symptom relief after traditional septoplasty are contradictory in reviewed publications 5.
In the last two decades the endoscopic Sino nasal surgery has been widely used including endoscopic approach for septoplasty. Endoscopic septoplasty as a minimally invasive technique where the dissection of the nasal septal flap can be limited minimizing trauma. The excellent visualization is presumed to decrease morbidity and post-operative swelling in isolated septal deviation by limiting the excision to the area of deviation 2. Furthermore, diagnosing and treating abnormalities of the lateral wall of the nose at the same sitting is only feasible in the endoscopic approach.
At the time of this study, there are no studies comparing the changes of quality of life in patients undergoing traditional septoplasty Vs endoscopic septoplasty.
The investigators aimed to assess whether endoscopic septoplasty is effective at improving patients QOL and reducing postoperative signs and complications.
Aims
Primary:
1\) To assess the differences in overall QOL between endoscopic and traditional septoplasty after adjusting for pertinent confounding variables.
Secondary:
1. To evaluate the post-operative complication rate in patients undergoing endoscopic septoplasty compared to traditional.
2. To evaluate the differences in the operation time between the two different approaches.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: