Clinical trial NCT05921396: Nasal Obstruction Compared by Rhinomanometry and Nasal Inspiratory Peak Flow After Endoscopic Nasal Surgery
Official title: Assessment of Nasal Obstruction, a Comparison Between Rhinomanometry and Nasal Inspiratory Peak Flow at Patients After Endoscopic Nasal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pituitary Adenoma Invasive
Nasal Obstruction
Keywords: Pituitary Adenoma
Nasal surgery
Rhinomanometry
Nasal inspiratory peak flow
Endoscopic nasal surgery
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
First posted: 2023-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study subjects will be enrolled into one study group.
Primary purpose: TREATMENT

Brief summary: The aim of the project is to determine whether nasal inspiratory peak flow is sufficient for preoperative and postoperative measurement of nasal patency compared to rhinomanometry.

Detailed description: The nasal cavity is used to heat, humidify and purify the air before entering other parts of the respiratory system. Other functions of the nose include in particular olfactory, immune, reflex, or sexual functions. Proper airflow through the nasal cavity is essential for all nasal functions; anatomical or flow changes can significantly affect nasal functions.

Endoscopic transnasal surgical approaches are modern, mini-invasive methods, enabling the solution of pathologies in the area of the cranial base, through the nasal cavity. The advantage of this technique is the absence of external incisions and scars and significantly better cosmetic effect, these methods also offer very good clarity and illumination of the operating field. The main disadvantage is the risk of affecting the functions of the nose. To create a transnasal approach to the skull base, it is necessary to perform lateralization of middle turbinates, resection of the anterior wall of the sphenoidal sinus, and resection of the posterior part of the nasal septum. These interventions are necessary for a good overview and manipulation in the operated area, however, they can lead to postoperative changes in the physiological functions of the nasal cavity, especially loss of smell, and taste, altered airflow through the nasal cavity, mucociliary transport disorders, nasal obstruction, crusting or drying mucous membrane. All these adverse changes significantly affect the patient's quality of life.

As a standard, rhinomanometry is used to measure nasal patency before and after surgery. A modern new method is measuring the patency of the nasal cavity using an NPIF (nasal peak inspiratory flow) device, which has significantly lower acquisition costs, is easy to use, and, above all, fast. The disadvantage is that the examination is less detailed, the result is the amount of air flowing in l/min through the nasal cavity.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma

Exclusion Criteria:

* patients after surgery of the nasal cavity or base of the skull
* patients with nasal disease and paranasal sinuses
* patients with olfactory disorders before surgery
* patients with nasal septal deviation that requires septoplasty

Primary outcomes:
measure: Comparison of nasal patency measurement using rhinomanometry and NPIF
timeFrame: 3 months
Secondary outcomes:
measure: Olfactory examination
timeFrame: 3 months
measure: Lund-Kennedy scoring system
timeFrame: 3 months
measure: SNOT 22 questionnaire
timeFrame: 3 months
measure: RhinoVAS questionnaire
timeFrame: 3 months
measure: Nose Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jakub Lubojacký, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messerer M, Cossu G, George M, Daniel RT. Endoscopic Endonasal Trans-sphenoidal Approach: Minimally Invasive Surgery for Pituitary Adenomas. J Vis Exp. 2018 Jan 17;(131):55896. doi: 10.3791/55896.
citation: Regmi D, Thapa A, Kc B, Shakya B. Endoscopic Endonasal Transsphenoidal Approach to Pituitary Adenoma: A Multi-disciplinary Approach. J Nepal Health Res Counc. 2017 Sep 8;15(2):174-177. doi: 10.3126/jnhrc.v15i2.18209.
citation: Rochet M, El-Hage W, Richa S, Kazour F, Atanasova B. Depression, Olfaction, and Quality of Life: A Mutual Relationship. Brain Sci. 2018 May 4;8(5):80. doi: 10.3390/brainsci8050080.
citation: Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15.
citation: Schreiber A, Bertazzoni G, Ferrari M, Rampinelli V, Verri P, Mattavelli D, Fontanella M, Nicolai P, Doglietto F. Nasal Morbidity and Quality of Life After Endoscopic Transsphenoidal Surgery: A Single-Center Prospective Study. World Neurosurg. 2019 Mar;123:e557-e565. doi: 10.1016/j.wneu.2018.11.212. Epub 2018 Dec 5.
citation: Rotenberg B, Tam S, Ryu WH, Duggal N. Microscopic versus endoscopic pituitary surgery: a systematic review. Laryngoscope. 2010 Jul;120(7):1292-7. doi: 10.1002/lary.20949.
citation: Soyka MB, Serra C, Regli L, Meier E, Holzmann D. Long-term olfactory outcome after nasoseptal flap reconstructions in midline skull base surgery. Am J Rhinol Allergy. 2017 Sep 1;31(5):334-337. doi: 10.2500/ajra.2017.31.4463.