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

NCT04782596 | Completed

• 1 other identifier: FNO-ENT-Septum
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

pituitary adenoma; nasal functions; posterior nasal septum resection; transnasal approach; endoscopic pituitary surgery

Outcome Measures

Primary Outcomes (3)

• Changes in nasal endoscopy

  Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)

  2 months

• 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

• Changes in RhinoVAS questionnaire

  RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)

  2 months

Secondary Outcomes (1)

• Changes in the quality of life

  2 months

Study Arms (2)

One-centimeter resection

EXPERIMENTAL

In the study subjects enrolled into this study arm, one-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure.

Procedure: Posterium nasal septum resection

Two-centimeter resection

EXPERIMENTAL

In the study subjects enrolled into this study arm, two-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure.

Procedure: Posterium nasal septum resection

Interventions

Posterium nasal septum resection PROCEDURE

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

One-centimeter resection; Two-centimeter resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• patients with functional pituitary adenoma indicating endoscopic transnasal extirpation of the pituitary adenoma

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related 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.

  PMID: 24119608 BACKGROUND

• 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.

  PMID: 26688432 BACKGROUND

• 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.

  PMID: 23520019 BACKGROUND

• 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.

  PMID: 31356005 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Jakub Lubojacký, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be randomised into two parallel groups.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)