Nasal Obstruction Compared by Rhinomanometry and Nasal Inspiratory Peak Flow After Endoscopic Nasal Surgery

NCT ID: NCT05921396

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pituitary Adenoma Invasive Nasal Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study subjects will be enrolled into one study group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal patency before and after pituitary adenoma surgery

Nasal patency in patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma.

Group Type EXPERIMENTAL

Nasal patency - rhinomanometry

Intervention Type PROCEDURE

Nasal patency before and after the pituitary adenoma surgery will be assessed using rhinomanometry.

Nasal patency - nasal inspiratory peak flow

Intervention Type PROCEDURE

Nasal patency before and after the pituitary adenoma surgery will be assessed using nasal inspiratory peak flow..

Interventions

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Nasal patency - rhinomanometry

Nasal patency before and after the pituitary adenoma surgery will be assessed using rhinomanometry.

Intervention Type PROCEDURE

Nasal patency - nasal inspiratory peak flow

Nasal patency before and after the pituitary adenoma surgery will be assessed using nasal inspiratory peak flow..

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ostrava

OTHER

Sponsor Role collaborator

University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakub Lubojacký, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jiří Hynčica

Role: CONTACT

+42059737 ext. 2587

Facility Contacts

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Jiří Hynčica

Role: primary

0042059737 ext. 2587

References

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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.

Reference Type BACKGROUND
PMID: 29364265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29016590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29734670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24429163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30528530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20578228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28859712 (View on PubMed)

Other Identifiers

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FNO/2023/RMM-NPIF

Identifier Type: -

Identifier Source: org_study_id

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