Suture-based, Minimally Invasive Technique Used to Correct NSD

Not Applicable

Terminated

• Conditions: Nasal Septum; Deviation, Congenital; Nasal Obstruction
• Interventions: Procedure: Suture-Septoplasty; Device: Surgical suture

• Registration Number: NCT04891263
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-18
• Study Start: 2021-08-02
• Primary Completion: 2021-09-13
• Study Completion: 2021-09-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suture-Septoplasty	Surgical suture	Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.
Suture-Septoplasty	Suture-Septoplasty	Participants will receive suture-septoplasty technique, and will be followed for three months postoperatively.

Primary Outcome Measures

Name	Time	Method
Nasal Obstruction Symptom Evaluation (NOSE) score	baseline, month 3	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

Name	Time	Method
Sino-Nasal Outcome Test (SNOT)-22 score	baseline, month 3	Unabbreviated scale title: Sino-Nasal Outcome Test. Mean change from baseline. Minimum value = 0, maximum value = 110. Higher score indicates a worse outcome.

Trial Locations

Locations (2)

Stanford Ambulatory Surgery Center, Stanford Hospital; 🇺🇸 Palo Alto, California, United States

Stanford Sinus Center/ Adult Comprehensive ENT Clinic; 🇺🇸 Stanford, California, United States