NCT05134831

Medical Rhinoplasty: Evaluation of the Efficacy of Hyaluronic Acid in the Treatment of Internal Nasal Valves.

Functional Medical Rhinoplasty: Objective Evaluation of the Efficacy of Hyaluronic Acid Injections in the Septo-triangular Angle in the Treatment of Internal Nasal Valves

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Nasal obstruction is a possible complication of rhinoplasty surgery. Several causes can explain it: deviation of the nasal septum, appearance of mucosal flanges inside the nasal cavity, but also collapse of the internal valve by its fragility. All surgeons performing rhinoplasty or rhinoseptoplasty are unfortunately confronted with this. Thus, when a rhinoplasty patient complains of postoperative nasal obstruction, the surgeon routinely performs several explorations: * Inspection of the nasal cavity with a nasofibroscope * Study of the nasal respiratory flows with a rhinomanometer The results of these 2 explorations allow to determine the cause of the obstruction and if it is explained or not by a collapse of the internal valve. When internal valve collapse is the cause of postoperative nasal obstruction, few alternatives exist to treat this problem. Revision surgery under general anesthesia is usually necessary, with placement of a cartilage graft (= spreader graft) in the septo-triangular angle to reopen and support it. An alternative treatment is the injection of hyaluronic acid into the septo-triangular angle instead of the cartilage graft placed in the operating room. This option has several advantages: it is performed during the consultation, no general anesthesia is required, the procedure is quick, the cost is much lower, the patient's nasal breathing improves immediately, and the post-procedure follow-up is simple. The aim of our study is therefore to objectively analyze the modification of nasal biomechanics after injection of hyaluronic acid in the septo-triangular angle in patients with internal nasal valve (post (septo)-rhinoplasty). This objective evaluation will be performed with a rhinomanometer, before and after injection. This is a simple, non-invasive measuring device that allows the measurement of the main physical variables governing the biomechanics of the fluids inside the nasal cavity, such as pressure, flow and therefore nasal resistance. The objective proof of such an efficiency will allow a better management of the patients, to universalize the practices, to decrease the cost of the treatment and eventually to bring arguments to the health authorities for the reimbursement of such procedures.

Conditions

• Nasal Obstruction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rhinomanometry	At Day 0, before the hyaluronic acid injection, the patient's nasal breathing is assessed by 4-phase rhinomanometry (bilaterally: right nostril AND left nostril). At Month 1, the patient's nasal breathing is re-assessed by 4-phase rhinomanometry, in the same conditions as Day 0.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-11-26
• Last updated: 2024-01-25