Suture-based, Minimally Invasive Technique Used to Correct NSD

Nasal Obstruction Clinical Trial

Official title:

Safety and Efficacy of Suture-Septoplasty for Chronic, Durable Correction of Nasal Septal Deviation Causing Nasal Obstruction Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04891263
• Other study ID #: 57545
• Status: Terminated
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: September 13, 2021

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 13, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Obstruction
• Nasal Septum; Deviation, Congenital

Intervention

Procedure:
• Suture-Septoplasty
Patients receive suture-septoplasty for repair of nasal septal deviation.

Device:
• Surgical suture
Suture used for closure during septoplasty surgery.

Locations

Country	Name	City	State
United States	Stanford Ambulatory Surgery Center, Stanford Hospital	Palo Alto	California
United States	Stanford Sinus Center/ Adult Comprehensive ENT Clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View Citation

Rigg BM. Suture materials in otoplasty. Plast Reconstr Surg. 1979 Mar;63(3):409-10. doi: 10.1097/00006534-197903000-00022. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, month 3
Secondary	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.	baseline, month 3