Pituitary AdenomaNCT04782596
Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
A study testing Posterium nasal septum resection in people with Pituitary Adenoma, run by University Hospital Ostrava at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Posterium nasal septum resection
- 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 Feb 2021to 31 Jan 2022
- 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 functional pituitary adenoma indicating 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 PND
- patients with olfactory disorders before surgery
- patients with nasal septal deviation
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
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.
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 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
- Conditions
- Pituitary Adenoma
- Being tested
- Posterium nasal septum resection
- Keywords
- pituitary adenoma, nasal functions, posterior nasal septum resection, transnasal approach, endoscopic pituitary surgery
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterium nasal septum resectionProcedure or surgery
Posterium nasal septum resection is required to ensure approach during transnasal endoscopic pituitary surgery in patients with pituitary adenoma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Posterium nasal septum resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nasal endoscopy
Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)
Measured: 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)
Measured: 2 months
Changes in RhinoVAS questionnaire
RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)
Measured: 2 months
Secondary outcomes (1)
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Feb 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be randomised into two parallel groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakub Lubojacký, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782596
- Sponsor's protocol ID
- FNO-ENT-Septum
- Status last verified
- Dec 2022
- First submitted
- 1 Mar 2021
- Last updated
- 7 Dec 2022
- 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. Individual participant data may be provided upon request.
Publications
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.
PubMed 24119608Rioja 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.
PubMed 26688432Bedrosian 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.
PubMed 23520019Bhenswala 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.
PubMed 31356005
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
- ClinicalTrials.gov ID
- NCT04782596
- Acronym / sponsor ID
- FNO-ENT-Septum
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary adenoma, nasal functions, posterior nasal septum resection, transnasal approach, endoscopic pituitary surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be randomised into two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| One-centimeter resection | Experimental | Procedure: Posterium nasal septum resectionIn the study subjects enrolled into this study arm, one-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure. |
| Two-centimeter resection | Experimental | Procedure: Posterium nasal septum resectionIn the study subjects enrolled into this study arm, two-centimetre resection will be used for the transnasal endoscopic pituitary surgery procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18 years
- patients with functional pituitary adenoma indicating endoscopic transnasal extirpation of the pituitary adenoma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterium nasal septum resectionPosterium nasal septum resection is required to ensure approach during transnasal endoscopic pituitary surgery in patients with pituitary adenoma. | Procedure or surgery | One-centimeter resection, Two-centimeter resection |
Primary outcome
Changes in nasal endoscopy
Time frame: 2 months
Nasal endoscopy will be performed to assess postoperative changes in nasal function (using Lund-Kennedy scoring system)
Changes in sino-nasal outcome test
Time frame: 2 months
Sino-nasal outcome test will be used to assess postoperative changes in nasal function (using standardised SNOT 22 questionnaire)
Changes in RhinoVAS questionnaire
Time frame: 2 months
RhinoVAS questionnaire will be used to assess postoperative changes in nasal function (using standardised RhinoVAS questionnaire)
1 secondary outcome
Changes in the quality of life
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 24119608Alobid 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.
- Background: PubMed 26688432Rioja 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.
- Background: PubMed 23520019Bedrosian 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.
- Background: PubMed 31356005Bhenswala 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. Individual participant data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub Lubojacký, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterium nasal septum resection in people with Pituitary Adenoma, 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: finished, as of the sponsor's last update on 7 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in nasal endoscopy (time frame: 2 months). The study lists 3 primary outcomes in all. 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 NCT04782596, which also lists 4 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 Dec 2022.