Suture-based, Minimally Invasive Technique Used to Correct NSD
NCT ID: NCT04891263
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2021-08-02
2021-09-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Suture-Septoplasty
Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.
Suture-Septoplasty
Patients receive suture-septoplasty for repair of nasal septal deviation.
Surgical suture
Suture used for closure during septoplasty surgery.
Interventions
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Suture-Septoplasty
Patients receive suture-septoplasty for repair of nasal septal deviation.
Surgical suture
Suture used for closure during septoplasty surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Recent surgery of any kind (\<1 month)
* Inpatients
* Previous nasal septum surgery
18 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Jayakar Nayak
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Neurosurgery at the Stanford University Medical Center
Principal Investigators
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Jayakar V Nayak, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center
Locations
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Stanford Ambulatory Surgery Center, Stanford Hospital
Palo Alto, California, United States
Stanford Sinus Center/ Adult Comprehensive ENT Clinic
Stanford, California, United States
Countries
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References
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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.
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.
Rigg BM. Suture materials in otoplasty. Plast Reconstr Surg. 1979 Mar;63(3):409-10. doi: 10.1097/00006534-197903000-00022.
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.
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.
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.
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.
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.
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.
Other Identifiers
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57545
Identifier Type: -
Identifier Source: org_study_id
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