Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
Primary Purpose
Pituitary Adenoma
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Posterium nasal septum resection
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Adenoma focused on measuring pituitary adenoma, nasal functions, posterior nasal septum resection, transnasal approach, endoscopic pituitary surgery
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
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
One-centimeter resection
Two-centimeter resection
Arm Description
In the study subjects enrolled into this study arm, one-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure.
In the study subjects enrolled into this study arm, two-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure.
Outcomes
Primary Outcome Measures
Changes in nasal endoscopy
Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)
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)
Changes in RhinoVAS questionnaire
RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04782596
First Posted
March 1, 2021
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT04782596
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital 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 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:
Anemization of the nasal mucosa using strips with diluted adrenaline 1: 1000.
Endoscopy of the nasal cavity and identification of important anatomical structures.
Lateralization of the middle and upper turbinates, identification of the anterior wall of the sphenoidal sinus and its natural ostium.
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.
Resection of the septum in the given range.
Resection of the anterior wall of the sphenoidal sinus, resection of the intersphenoidal septum.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
Keywords
pituitary adenoma, nasal functions, posterior nasal septum resection, transnasal approach, endoscopic pituitary surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be randomised into two parallel groups.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One-centimeter resection
Arm Type
Experimental
Arm Description
In the study subjects enrolled into this study arm, one-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure.
Arm Title
Two-centimeter resection
Arm Type
Experimental
Arm Description
In the study subjects enrolled into this study arm, two-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure.
Intervention Type
Procedure
Intervention Name(s)
Posterium nasal septum resection
Intervention Description
Posterium nasal septum resection is required to ensure approach during transnasal endoscopic pituitary surgery in patients with pituitary adenoma.
Primary Outcome Measure Information:
Title
Changes in nasal endoscopy
Description
Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)
Time Frame
2 months
Title
Changes in sino-nasal outcome test
Description
Sino-nasal outcome test will be used to assess postoperative changes in nasal function (using standardised SNOT 22 questionnaire)
Time Frame
2 months
Title
Changes in RhinoVAS questionnaire
Description
RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Changes in the quality of life
Description
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)
Time Frame
2 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 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
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
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. Individual participant data may be provided upon request.
Citations:
PubMed Identifier
24119608
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.
Results Reference
background
PubMed Identifier
26688432
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.
Results Reference
background
PubMed Identifier
23520019
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.
Results Reference
background
PubMed Identifier
31356005
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.
Results Reference
background
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Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
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