Suture-based, Minimally Invasive Technique Used to Correct NSD

Stanford University4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasal Septum; Deviation, Congenital Nasal Obstruction

Interventions

Suture-SeptoplastyPROCEDURE

Patients receive suture-septoplasty for repair of nasal septal deviation.

Surgical sutureDEVICE

Suture used for closure during septoplasty surgery.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Stanford Ambulatory Surgery Center, Stanford Hospital

Palo Alto, California, United States

Stanford Sinus Center/ Adult Comprehensive ENT Clinic

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline, month 3

Secondary Outcomes

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.

Time frame: baseline, month 3

Data from ClinicalTrials.gov

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