Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum

NCT ID: NCT02653950

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

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.

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.

Conditions

Intranasal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional

a control arm of patients undergoing traditional septoplasty for DNS

Group Type: ACTIVE_COMPARATOR

Traditional septoplasty

Intervention Type: PROCEDURE

septoplasty under direct vision

Endoscopic

patients undergoing endoscopic septoplasty.

Group Type: EXPERIMENTAL

Endoscopic septoplasty

Intervention Type: PROCEDURE

Endoscopic surgery; septoplasty with or without middle turbenectomy

Interventions

Endoscopic septoplasty

Endoscopic surgery; septoplasty with or without middle turbenectomy

Intervention Type: PROCEDURE

Traditional septoplasty

septoplasty under direct vision

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

SHOROOK NA'ARA MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shorook Na'ara, MD

Role: CONTACT

shorook.n@gmail.com

00972507977510

References

Na'ara S, Kaptzan B, Gil Z, Ostrovsky D. Endoscopic Septoplasty Versus Traditional Septoplasty for Treating Deviated Nasal Septum: A Prospective, Randomized Controlled Trial. Ear Nose Throat J. 2021 Nov;100(9):673-678. doi: 10.1177/0145561320918982. Epub 2020 Apr 27.

Reference Type: DERIVED

PMID: 32339048 (View on PubMed)

Other Identifiers

0576-15-RMB

Identifier Type: -

Identifier Source: org_study_id