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

Primary Purpose

Pituitary Adenoma Invasive, Nasal Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Nasal patency - rhinomanometry
Nasal patency - nasal inspiratory peak flow
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma Invasive focused on measuring Pituitary Adenoma, Nasal surgery, Rhinomanometry, Nasal inspiratory peak flow, Endoscopic nasal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal patency before and after pituitary adenoma surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Comparison of nasal patency measurement using rhinomanometry and NPIF
Comparison of nasal patency measurement using rhinomanometry and Nasal Peak Inspiratory Flow (NPIF) will be performed at the preoperative examination, 1 month and 3 months after surgery. The volume will be measured in L/min. Rhinomanometry is a standard diagnostic tool aiming to objectively evaluate the respiratory function of the nose. It measures pressure and flow during normal inspiration and expiration through the nose. Nasal peak inspiratory flow (NPIF) measures the maximum airflow a patient is able to produce during forced nasal inspiration and is a measure of nasal patency.

Secondary Outcome Measures

Olfactory examination
Olfactory examination (test of identification and discrimination with perfumed markers) will be performed at the preoperative examination, 1 month and 3 months after surgery.
Lund-Kennedy scoring system
Evaluation of the nasal cavity and patency using the Lund-Kennedy scoring system (evaluation of edema, secretion, crust) will be performed at the preoperative examination, 1 month and 3 months after surgery. The total scores will be compared. The Lund-Kennedy score is a validated scale by which physicians rate the endoscopic appearance of the sinonasal cavity. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. A higher score represents a worse endoscopic appearance.
SNOT 22 questionnaire
Sino-Nasal Outcome Test-22 (SNOT 22) Questionnaire (version 4) - patients will complete a list of symptoms and social/emotional consequences of their nasal disorder. The SNOT-22 is a validated scale that measures sinonasal symptoms in patients with sinusitis. The 22 questions are scored on a scale of 0-5 with a maximum total score of 110. Higher scores represent more symptomatic patients.
RhinoVAS questionnaire
Rhino Visual Analogue Scale (RhinoVAS) questionnaire will be used to assess postoperative changes in nasal function ranging from 0 (complete nose patency) to 10 cm (complete nose obstruction).
Nose Score
A simple, five-question, validated survey that uses a 20-point scale to capture breathing symptoms, with higher scores indicating more severe symptoms than lower scores. A score of 0 means no problems with nasal obstruction and a score of 100 means the worst possible problems with nasal obstruction.

Full Information

First Posted
June 16, 2023
Last Updated
September 6, 2023
Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT05921396
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma Invasive, Nasal Obstruction
Keywords
Pituitary Adenoma, Nasal surgery, Rhinomanometry, Nasal inspiratory peak flow, Endoscopic nasal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study subjects will be enrolled into one study group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal patency before and after pituitary adenoma surgery
Arm Type
Experimental
Arm Description
Nasal patency in patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma.
Intervention Type
Procedure
Intervention Name(s)
Nasal patency - rhinomanometry
Intervention Description
Nasal patency before and after the pituitary adenoma surgery will be assessed using rhinomanometry.
Intervention Type
Procedure
Intervention Name(s)
Nasal patency - nasal inspiratory peak flow
Intervention Description
Nasal patency before and after the pituitary adenoma surgery will be assessed using nasal inspiratory peak flow..
Primary Outcome Measure Information:
Title
Comparison of nasal patency measurement using rhinomanometry and NPIF
Description
Comparison of nasal patency measurement using rhinomanometry and Nasal Peak Inspiratory Flow (NPIF) will be performed at the preoperative examination, 1 month and 3 months after surgery. The volume will be measured in L/min. Rhinomanometry is a standard diagnostic tool aiming to objectively evaluate the respiratory function of the nose. It measures pressure and flow during normal inspiration and expiration through the nose. Nasal peak inspiratory flow (NPIF) measures the maximum airflow a patient is able to produce during forced nasal inspiration and is a measure of nasal patency.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Olfactory examination
Description
Olfactory examination (test of identification and discrimination with perfumed markers) will be performed at the preoperative examination, 1 month and 3 months after surgery.
Time Frame
3 months
Title
Lund-Kennedy scoring system
Description
Evaluation of the nasal cavity and patency using the Lund-Kennedy scoring system (evaluation of edema, secretion, crust) will be performed at the preoperative examination, 1 month and 3 months after surgery. The total scores will be compared. The Lund-Kennedy score is a validated scale by which physicians rate the endoscopic appearance of the sinonasal cavity. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. A higher score represents a worse endoscopic appearance.
Time Frame
3 months
Title
SNOT 22 questionnaire
Description
Sino-Nasal Outcome Test-22 (SNOT 22) Questionnaire (version 4) - patients will complete a list of symptoms and social/emotional consequences of their nasal disorder. The SNOT-22 is a validated scale that measures sinonasal symptoms in patients with sinusitis. The 22 questions are scored on a scale of 0-5 with a maximum total score of 110. Higher scores represent more symptomatic patients.
Time Frame
3 months
Title
RhinoVAS questionnaire
Description
Rhino Visual Analogue Scale (RhinoVAS) questionnaire will be used to assess postoperative changes in nasal function ranging from 0 (complete nose patency) to 10 cm (complete nose obstruction).
Time Frame
3 months
Title
Nose Score
Description
A simple, five-question, validated survey that uses a 20-point scale to capture breathing symptoms, with higher scores indicating more severe symptoms than lower scores. A score of 0 means no problems with nasal obstruction and a score of 100 means the worst possible problems with nasal obstruction.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
+42059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Lubojacký, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Petr Matoušek, MD,PhD,MBA
First Name & Middle Initial & Last Name & Degree
Jakub Lubojacký, MD
First Name & Middle Initial & Last Name & Degree
Michaela Mladoňová, MD
First Name & Middle Initial & Last Name & Degree
Petr Kántor, MD
First Name & Middle Initial & Last Name & Degree
Viktorie Hránková, MD
First Name & Middle Initial & Last Name & Degree
Pavel Komínek, Prof.,MD,PhD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
29364265
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.
Results Reference
background
PubMed Identifier
29016590
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.
Results Reference
background
PubMed Identifier
29734670
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.
Results Reference
background
PubMed Identifier
24429163
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.
Results Reference
background
PubMed Identifier
30528530
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.
Results Reference
background
PubMed Identifier
20578228
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.
Results Reference
background
PubMed Identifier
28859712
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.
Results Reference
background

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

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