Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

Официальное название

Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial

Обзор

The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.

Подробное описание

One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.

Вмешательства

• Процедура Batten batten graft
  The batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration.
• Процедура Septoplasty
  A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
• Процедура Inferior Turbinate Reduction
  The bilateral inferior turbinates will be surgically ablated.

Первичные конечные точки

• Nasal Obstruction Symptom Evaluation (NOSE) score [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Lateral Wall Insufficiency (LWI) scores [Срок оценки: 12 months]
• Peak Inspiratory Flow Rate (PIFR) [Срок оценки: 12 months]
• Complications and side-effects [Срок оценки: 12 months]
• Cost-effectiveness (EQ-5D-5L) [Срок оценки: 12 month]
• Reoperation incidence [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients should satisfy all the following criteria to be considered eligible for randomization:

• Be age 18 or above
• Able to provide written informed consent
• Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.

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• Septal deviation must be present on direct or endoscopic examination
• Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
• Collapse of external nasal valve and/or lateral motion instability must be documented

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• The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.

In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.

Критерии исключения

• Septal perforation
• History of previous functional rhinoplasty or sinus or septal surgery
• Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
• Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
• Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Poplar Bluff Regional Medical Center — Poplar Bluff
• Lenox Hill Hospital/Staten Island University Hospital — New York
• Staten Island University Hospital — Staten Island

Идентификаторы

NCT: NCT05287841 · 21-0204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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