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Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653950
Recruitment Status : Unknown
Verified January 2016 by SHOROOK NA'ARA MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
SHOROOK NA'ARA MD, Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Intranasal Surgery Procedure: Endoscopic septoplasty Procedure: Traditional septoplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Traditional
a control arm of patients undergoing traditional septoplasty for DNS
Procedure: Traditional septoplasty
septoplasty under direct vision

Experimental: Endoscopic
patients undergoing endoscopic septoplasty.
Procedure: Endoscopic septoplasty
Endoscopic surgery; septoplasty with or without middle turbenectomy




Primary Outcome Measures :
  1. Change in Quality of life [ Time Frame: Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery. ]
    quality of life will assessed using Sino-Nasal Outcome Test-22 (SNOT-22) scores.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
  2. Patient undergoing surgery for repairing the deviated nasal septum.

Exclusion Criteria:

  1. Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
  2. Patients undergoing endoscopic sinonasal surgery.
  3. Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
  4. Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
  5. Patients listed for revision surgery
  6. Neoplasms - untreated or under active or recent treatment with chemotherapy or radiotherapy
  7. Unable to give informed consent due to mental impairment
  8. Unable to adhere follow up or treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653950


Contacts
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Contact: Shorook Na'ara, MD 00972507977510 shorook.n@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus
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Responsible Party: SHOROOK NA'ARA MD, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02653950    
Other Study ID Numbers: 0576-15-RMB
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016