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Suture-based, Minimally Invasive Technique Used to Correct NSD

Primary Purpose

Nasal Septum; Deviation, Congenital, Nasal Obstruction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suture-Septoplasty
Surgical suture
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Septum; Deviation, Congenital focused on measuring septoplasty, suture-septoplasty, excisional septoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18
  • Patients from all ethnic and geographic backgrounds within the Stanford Sinus Center with symptomatic NSD
  • Primary patients with NSD without past septum surgery
  • Patients who have failed maximum medical therapy
  • Patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon

Exclusion Criteria:

  • Age < 18
  • Recent surgery of any kind (<1 month)
  • Inpatients
  • Previous nasal septum surgery

Sites / Locations

  • Stanford Ambulatory Surgery Center, Stanford Hospital
  • Stanford Sinus Center/ Adult Comprehensive ENT Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suture-Septoplasty

Arm Description

Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.

Outcomes

Primary Outcome Measures

Nasal Obstruction Symptom Evaluation (NOSE) score
Unabbreviated scale title: Nasal Obstruction Symptom Evaluation. Mean change from baseline. Minimum value = 0, maximum value = 100. Higher score indicates a worse outcome.

Secondary Outcome Measures

Sino-Nasal Outcome Test (SNOT)-22 score
Unabbreviated scale title: Sino-Nasal Outcome Test. Mean change from baseline. Minimum value = 0, maximum value = 110. Higher score indicates a worse outcome.

Full Information

First Posted
May 13, 2021
Last Updated
March 30, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04891263
Brief Title
Suture-based, Minimally Invasive Technique Used to Correct NSD
Official Title
Safety and Efficacy of Suture-Septoplasty for Chronic, Durable Correction of Nasal Septal Deviation Causing Nasal Obstruction Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties due to COVID-19 pandemic
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Nasal Septal Deviation (NSD) is one of the most common indications for surgery seen by ENT physicians, however, correction requires open surgery which is associated with several weeks of recovery. The purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address NSD.
Detailed Description
Nasal obstruction due to structural issues such as nasal septal deviation (NSD) is remarkably common. NSD is caused by warping of the midline cartilage and bone of the septum, which starts between the 2 nostrils, and extends 7 cm posteriorly to the nasopharynx. This crooked or deviated conformation in the nasal septum cartilage and/or bone leads to physical blockade of normal airflow through the nose, often leading to complaints of nasal congestion, sleep disturbance, exercise limitations, and even poor compliance with CPAP mask use for treatment of obstructive sleep apnea (OSA). To correct this structural issue in symptomatic patients, septoplasty surgery under general anesthesia is typically advocated. As an alternative to standard septoplasty, there are rare reports of simplified suture techniques that may be used to straighten the nasal septal cartilage. However, virtually all published studies to our knowledge have still required 1) some degree of cartilage/bone excision, which can destabilize the nasal support framework, and 2) use of non-locking sutures which can break, provide insufficient support, and be technically challenging given that it requires knot tying within the narrow nasal cavity corridors. The investigators have demonstrated in benchtop models that similar results to standard septoplasty techniques can may be achieved with the use of a non-retractable suture without the need for cartilage excision. This technique, therefore, could allow for a simple, and knotless, minimally invasive way to improve and/or correct symptomatic NSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Septum; Deviation, Congenital, Nasal Obstruction
Keywords
septoplasty, suture-septoplasty, excisional septoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suture-Septoplasty
Arm Type
Experimental
Arm Description
Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Suture-Septoplasty
Intervention Description
Patients receive suture-septoplasty for repair of nasal septal deviation.
Intervention Type
Device
Intervention Name(s)
Surgical suture
Other Intervention Name(s)
PDS suture
Intervention Description
Suture used for closure during septoplasty surgery.
Primary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation (NOSE) score
Description
Unabbreviated scale title: Nasal Obstruction Symptom Evaluation. Mean change from baseline. Minimum value = 0, maximum value = 100. Higher score indicates a worse outcome.
Time Frame
baseline, month 3
Secondary Outcome Measure Information:
Title
Sino-Nasal Outcome Test (SNOT)-22 score
Description
Unabbreviated scale title: Sino-Nasal Outcome Test. Mean change from baseline. Minimum value = 0, maximum value = 110. Higher score indicates a worse outcome.
Time Frame
baseline, month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Patients from all ethnic and geographic backgrounds within the Stanford Sinus Center with symptomatic NSD Primary patients with NSD without past septum surgery Patients who have failed maximum medical therapy Patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon Exclusion Criteria: Age < 18 Recent surgery of any kind (<1 month) Inpatients Previous nasal septum surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayakar V Nayak, M.D., Ph.D.
Organizational Affiliation
Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Ambulatory Surgery Center, Stanford Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Sinus Center/ Adult Comprehensive ENT Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only research personal listed in the IRB will have full access to PHI upon approval of the protocol director. All other participants conducting research pertaining to this study will receive anonymous information related to patient outcome that will not be linked to a patient identifier (including participant ID numbers).
Citations:
PubMed Identifier
31227374
Citation
van Egmond MMHT, Rovers MM, Hannink G, Hendriks CTM, van Heerbeek N. Septoplasty with or without concurrent turbinate surgery versus non-surgical management for nasal obstruction in adults with a deviated septum: a pragmatic, randomised controlled trial. Lancet. 2019 Jul 27;394(10195):314-321. doi: 10.1016/S0140-6736(19)30354-X. Epub 2019 Jun 18.
Results Reference
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PubMed Identifier
3697576
Citation
Tan KH. Long-term survey of prominent ear surgery: a comparison of two methods. Br J Plast Surg. 1986 Apr;39(2):270-3. doi: 10.1016/0007-1226(86)90100-1.
Results Reference
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PubMed Identifier
154115
Citation
Rigg BM. Suture materials in otoplasty. Plast Reconstr Surg. 1979 Mar;63(3):409-10. doi: 10.1097/00006534-197903000-00022.
Results Reference
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PubMed Identifier
11074836
Citation
Boenisch M, Mink A. Clinical and histological results of septoplasty with a resorbable implant. Arch Otolaryngol Head Neck Surg. 2000 Nov;126(11):1373-7. doi: 10.1001/archotol.126.11.1373.
Results Reference
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PubMed Identifier
15692369
Citation
Gruber RP, Nahai F, Bogdan MA, Friedman GD. Changing the convexity and concavity of nasal cartilages and cartilage grafts with horizontal mattress sutures: part I. Experimental results. Plast Reconstr Surg. 2005 Feb;115(2):589-94. doi: 10.1097/01.prs.0000150145.39509.db.
Results Reference
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PubMed Identifier
15692370
Citation
Gruber RP, Nahai F, Bogdan MA, Friedman GD. Changing the convexity and concavity of nasal cartilages and cartilage grafts with horizontal mattress sutures: part II. Clinical results. Plast Reconstr Surg. 2005 Feb;115(2):595-606; discussion 607-8. doi: 10.1097/01.prs.0000150146.04465.81.
Results Reference
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PubMed Identifier
32332542
Citation
Seo HJ, Denadai R, Vamvanij N, Chinpaisarn C, Lo LJ. Primary Rhinoplasty Does Not Interfere with Nasal Growth: A Long-Term Three-Dimensional Morphometric Outcome Study in Patients with Unilateral Cleft. Plast Reconstr Surg. 2020 May;145(5):1223-1236. doi: 10.1097/PRS.0000000000006744.
Results Reference
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PubMed Identifier
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Citation
Rohrich RJ, Friedman RM, Liland DL. Comparison of otoplasty techniques in the rabbit model. Ann Plast Surg. 1995 Jan;34(1):43-7. doi: 10.1097/00000637-199501000-00009.
Results Reference
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PubMed Identifier
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Citation
Boenisch M, Tamas H, Nolst Trenite GJ. Influence of polydioxanone foil on growing septal cartilage after surgery in an animal model: new aspects of cartilage healing and regeneration (preliminary results). Arch Facial Plast Surg. 2003 Jul-Aug;5(4):316-9. doi: 10.1001/archfaci.5.4.316.
Results Reference
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Suture-based, Minimally Invasive Technique Used to Correct NSD

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