Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions

Pituitary Adenoma Clinical Trial

Official title:

Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782596
• Other study ID #: FNO-ENT-Septum
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• Posterium nasal septum resection
Posterium nasal septum resection is required to ensure approach during transnasal endoscopic pituitary surgery in patients with pituitary adenoma.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View 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. — View 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. Review. — View Citation

Rioja E, Bernal-Sprekelsen M, Enriquez K, Enseñat 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nasal endoscopy	Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)	2 months
Primary	Changes in sino-nasal outcome test	Sino-nasal outcome test will be used to assess postoperative changes in nasal function (using standardised SNOT 22 questionnaire)	2 months
Primary	Changes in RhinoVAS questionnaire	RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)	2 months
Secondary	Changes in the quality of life	Changes in the quality of life of study subjects will be assessed using standard quality of life measurement tools (e.g. Health-Related Quality of Life - HRQL)	2 months