Traditional Septoplasty Vs Endoscopic Septoplasty for Treating Deviated Nasal Septum
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedJanuary 13, 2016
January 1, 2016
3 years
January 6, 2016
January 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Quality of life
quality of life will assessed using Sino-Nasal Outcome Test-22 (SNOT-22) scores.
Baseline (maximum 3 months before surgery), at 2-3 weeks, and 3-4 months after the surgery.
Study Arms (2)
Traditional
ACTIVE COMPARATORa control arm of patients undergoing traditional septoplasty for DNS
Endoscopic
EXPERIMENTALpatients undergoing endoscopic septoplasty.
Interventions
Endoscopic surgery; septoplasty with or without middle turbenectomy
Eligibility Criteria
You may qualify if:
- Diagnosis of nasal obstruction and deviated nasal septum with or without hypertrophy of nasal turbinates.
- Patient undergoing surgery for repairing the deviated nasal septum.
You may not qualify if:
- Diagnosis of bilateral acute or chronic rhinosinusitis or nasal polyposis
- Patients undergoing endoscopic sinonasal surgery.
- Diagnosed with inflammatory (e.g. Wegener's granulomatosis, sarcoidosis) or neoplastic nasal pathology
- Diagnosed with systemic conditions affecting the nose e.g. Cystic fibrosis, Kartagener's syndrome
- Patients listed for revision surgery
- Neoplasms - untreated or under active or recent treatment with chemotherapy or radiotherapy
- Unable to give informed consent due to mental impairment
- Unable to adhere follow up or treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32339048DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 6, 2016
First Posted
January 13, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2019
Last Updated
January 13, 2016
Record last verified: 2016-01