Clinical trial NCT04891263: 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
Overall status: TERMINATED
Phase: NA
Conditions: Nasal Septum; Deviation, Congenital
Nasal Obstruction
Keywords: septoplasty
suture-septoplasty
excisional septoplasty
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation (NOSE) score
timeFrame: baseline, month 3
Secondary outcomes:
measure: Sino-Nasal Outcome Test (SNOT)-22 score
timeFrame: baseline, month 3
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Ambulatory Surgery Center, Stanford Hospital
state: California
city: Stanford
country: United States
facility: Stanford Sinus Center/ Adult Comprehensive ENT Clinic
state: California
Study officials:
affiliation: Associate Professor of Otolaryngology - Head & Neck Surgery, Stanford University Medical Center
name: Jayakar V Nayak, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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