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Pituitary Adenoma InvasiveNCT05921396

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

A study testing Nasal patency - rhinomanometry and Nasal patency - nasal inspiratory peak flow in people with Pituitary Adenoma Invasive and Nasal Obstruction, run by University Hospital Ostrava at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pituitary Adenoma Invasive, Nasal Obstruction
What is being tested?
Nasal patency - rhinomanometry and Nasal patency - nasal inspiratory peak flow
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCzechia
Study dates
1 Jul 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jiří Hynčica contact

+42059737 ext. 2587

jiri.hyncica@fno.cz

Czechia1 site, 1 recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

    Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz

    Petr Matoušek, MD,PhD,MBA

    Recruiting

Other trials in Czechia

About this study

Official title: Assessment of Nasal Obstruction, a Comparison Between Rhinomanometry and Nasal Inspiratory Peak Flow at Patients After Endoscopic Nasal Surgery

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.

Read the 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.

Being tested
Nasal patency - rhinomanometry, Nasal patency - nasal inspiratory peak flow
Keywords
Pituitary Adenoma, Nasal surgery, Rhinomanometry, Nasal inspiratory peak flow, Endoscopic nasal surgery
Medical subject headings
Nasal Obstruction, Pituitary Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal patency - rhinomanometryProcedure or surgery

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

  • Nasal patency - nasal inspiratory peak flowProcedure or surgery

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

Study groups in NCT05921396
Study groupRoleWhat they receive
Nasal patency before and after pituitary adenoma surgeryExperimentalNasal patency in patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma.
Receives: Procedure: Nasal patency - rhinomanometry; Procedure: Nasal patency - nasal inspiratory peak flow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (5)

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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).

    Measured: 3 months

  5. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start1 Jul 2023
  3. Primary completionJan 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study subjects will be enrolled into one study group.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921396
Sponsor's protocol ID
FNO/2023/RMM-NPIF
Status last verified
Sep 2023
First submitted
16 Jun 2023
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers.

Publications

  • 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.

    PubMed 29364265

  • 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.

    PubMed 29016590

  • 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.

    PubMed 29734670

  • 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.

    PubMed 24429163

  • 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.

    PubMed 30528530

  • 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.

    PubMed 20578228

  • 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.

    PubMed 28859712

Questions about this trial

What is this clinical trial studying?

A study testing Nasal patency - rhinomanometry and Nasal patency - nasal inspiratory peak flow in people with Pituitary Adenoma Invasive and Nasal Obstruction, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiří Hynčica (+42059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of nasal patency measurement using rhinomanometry and NPIF (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05921396, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

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