Clinical trial NCT04782596: Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
Official title: Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Adenoma
Keywords: pituitary adenoma
nasal functions
posterior nasal septum resection
transnasal approach
endoscopic pituitary surgery
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be randomised into two parallel groups.
Primary purpose: TREATMENT

Brief summary: The aim of the project is to compare the effect of different extent of resection of the posterior part of the septum on the postoperative nasal functions.

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 solution of pathologies in the area of the cranial base, through the nasal cavity. The advantage of this technique is absence of external incisions and scars and significantly better cosmetic effect, these methods also offer very good clarity and illumination of the operating field. Main disadvantage is risk of affecting functions of the nose.

To create a transnasal approach to skull base, it is necessary to perform lateralization of middle turbinates, resection of anterior wall of sphenoidal sinus and resection of 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, taste, altered airflow through the nasal cavity, mucociliary transport disorders, nasal obstruction, crusting or drying mucous membrane. All these adverse changes significantly affect patient's quality of life.

Larger extent of septal resection allows the surgeon to have a better overview and manoeuvrability in the operated area, which allows sufficient radicality and allows the solution of possible complications. On the other hand, greater resection also means greater interference with the anatomy of the nasal cavity and possible influence on nasal functions.

The aim of the project is to compare the effect of different extent of resection of the posterior part of the septum on the postoperative nasal functions.

Study design:

* all operations will be performed by the same operations team
* prior to surgery, patients will be randomly tossed into two groups according to the extent of resection of the posterior edge of the septum as part of the transsphenoidal approach during cranial base surgery
* group A - Patients will be resected with a posterior 1 cm nasal septum as part of a transsphenoidal approach.
* group B - Patients will be resected with a 2 cm posterior nasal septum as part of a transsphenoidal approach
* if the selected extent of resection is not sufficient during surgery for group A, it will be extended so that the lesion can be safely removed, and patient will be removed from study

Operational procedure:

1. Anemization of the nasal mucosa using strips with diluted adrenaline 1: 1000.
2. Endoscopy of the nasal cavity and identification of important anatomical structures.
3. Lateralization of the middle and upper turbinates, identification of the anterior wall of the sphenoidal sinus and its natural ostium.
4. Apply suction with a marked distance of 1 and 2 cm to the septum and mark the extent of laser resection on the septal mucosa.

   The suction is applied paraseptally to the anterior wall of the sphenoidal sinus at the height of the natural ostium (1.5 cm above the upper edge of the choana), the caudal border of the resection is the height of the upper edge of the choana, the cranial border is the ceiling of the sphenoid.
5. Resection of the septum in the given range.
6. Resection of the anterior wall of the sphenoidal sinus, resection of the intersphenoidal septum.
7. Rest of the operation is identical in both groups of patients (tumour resection, revision of the nasal cavity, nasal tamponade).

   * At preoperative examination and 1 month after surgery, patients will have:
   * endoscopy of the nasal cavity with Lund-Kennedy scoring system (evaluation of oedema, secretion, crust)
   * olfactory examination - test of identification and discrimination with perfumed markers
   * SNOT 22 questionnaire
   * RhinoVAS questionnaire
   * Nose score

Statistical evaluation:

* comparison of nasal functions after cranial base surgery in patients with a range of resection of the posterior edge of the septum 1 cm and 2 cm
* comparison of olfactory before and after surgery in both groups of patients

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* patients with functional pituitary adenoma indicating 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 PND
* patients with olfactory disorders before surgery
* patients with nasal septal deviation

Primary outcomes:
measure: Changes in nasal endoscopy
timeFrame: 2 months
measure: Changes in sino-nasal outcome test
timeFrame: 2 months
measure: Changes in RhinoVAS questionnaire
timeFrame: 2 months
Secondary outcomes:
measure: Changes in the quality of life
timeFrame: 2 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: Alobid I, Ensenat J, Marino-Sanchez F, Rioja E, de Notaris M, Mullol J, Bernal-Sprekelsen M. Expanded endonasal approach using vascularized septal flap reconstruction for skull base tumors has a negative impact on sinonasal symptoms and quality of life. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):426-31. doi: 10.2500/ajra.2013.27.3932.
citation: Rioja E, Bernal-Sprekelsen M, Enriquez K, Ensenat J, Valero R, de Notaris M, Mullol J, Alobid I. Long-term outcomes of endoscopic endonasal approach for skull base surgery: a prospective study. Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1809-17. doi: 10.1007/s00405-015-3853-9. Epub 2015 Dec 19.
citation: Bedrosian JC, McCoul ED, Raithatha R, Akselrod OA, Anand VK, Schwartz TH. A prospective study of postoperative symptoms in sinonasal quality-of-life following endoscopic skull-base surgery: dissociations based on specific symptoms. Int Forum Allergy Rhinol. 2013 Aug;3(8):664-9. doi: 10.1002/alr.21161. Epub 2013 Mar 20.
citation: Bhenswala PN, Schlosser RJ, Nguyen SA, Munawar S, Rowan NR. Sinonasal quality-of-life outcomes after endoscopic endonasal skull base surgery. Int Forum Allergy Rhinol. 2019 Oct;9(10):1105-1118. doi: 10.1002/alr.22398. Epub 2019 Jul 29.