Pituitary TumorNCT03773705
Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery
A study testing Electrocautery versus scalpel in people with Pituitary Tumor and Surgery, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Pituitary tumours have an estimated prevalence of 20% in the general population and the number of clinically relevant pituitary adenomas is increasing with time. When symptomatic, the standard of care required for pituitary adenomas is resection through an endoscopic transsphenoidal approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Tumor, Surgery, Olfactory Nerve Injuries
- What is being tested?
- Electrocautery versus scalpel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2019to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥18 years)
- Patients with tumours of the pituitary gland electively scheduled for endoscopic transsphenoidal surgery with nasoseptal flap coverage
Who cannot join
- Documented evidence of sinonasal disease on either nasal endoscopy or radiography
- Patients with a clinical history of asthma and/or sinonasal disease
- Previous sinus surgery
- Previous skull base surgery
- History of pre-existing hyposmia or anosmia
- Use of medication(s) known to alter sense of smell at time of test
- UPSIT scores <5 indicating a functional component to alteration in olfaction
- Development of postoperative cerebrospinal fluid leak necessitating re-entry into the operative field containing the nasoseptal flap
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Andrea Figol, MSc, 416-864-6060 ext. 6591, FigolA@smh.ca
About this study
Official title: Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery: A Single-blinded Randomized Controlled Trial
Pituitary tumours have an estimated prevalence of 20% in the general population and the number of clinically relevant pituitary adenomas is increasing with time. When symptomatic, the standard of care required for pituitary adenomas is resection through an endoscopic transsphenoidal approach. There is however significant olfactory dysfunction following endoscopic transsphenoidal pituitary surgery with approximately 23% of patients reporting some degree of worsening in their sense of smell in the postoperative period.
Pedicled nasoseptal flaps are used to repair skull base defects following resection of skull base tumours. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. The use of electrocautery in surgery has provided surgeons with greater hemostasis when compared to a scalpel. This is of utmost importance in many regions of the head \& neck where highly vascularized tissue results in difficulties achieving adequate hemostasis and therefore limiting view of the surgical field. However, the use of electrocautery increases thermal damage to surrounding tissue and impairs wound healing when compared to a scalpel.
Although the transmission of thermal energy via electrocautery to adjacent mucosa containing olfactory epithelium may theoretically contribute to olfactory disturbances, no prospective randomized controlled trials have yet examined the impact of these two different techniques on postoperative olfactory function. The purpose of this research study is to determine the effects, if any, of electrocautery versus scalpel on olfaction in raising the nasoseptal flap for repairing skull base defects following transphenoidal surgery.
Read the detailed description
Pedicled nasoseptal flaps are used to repair skull base defects following endoscopic transphenoidal surgery. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. While it is hypothesized that the olfactory mucosa is at greater risk of thermal injury with the use of electrocautery, no prospective multi-center studies have examined the impact of these two different techniques on postoperative olfactory function.
Patients will be recruited through the Otolaryngology-Head \& Neck Surgery clinics. Based on previous studies in a North American population, a 10% change in UPSIT score was considered to be significant. With an alpha error set to 0.05, a beta of 0.8 and an effect size of 1 standard deviation, a sample size of 20 was calculated.
After obtaining consent for enrolment into the study, each patient will undergo either: (1) electrocautery or (2) scalpel in the elevation of nasoseptal flaps based on primary surgeon preference. The University of Pennsylvania Smell Identification Test (UPSIT) will be used for baseline testing of olfactory function in all enrolled patients. Postoperatively, all enrolled patients will be seen in follow-up at 1, 3 and 6 months' time, at which point the UPSIT will be administered for testing of postoperative olfactory function.
The Wilcoxon signed-rank test will be used to determine differences between UPSIT scores pre- and postoperatively. Results of p<0.05 will be considered statistically significant. Linear regression will be used to examine relationships between UPSIT scores and other variables collected (e.g., demographic data, size/type of pituitary tumour, length of nasoseptal flap).
Given that approximately 23% of all patients who undergo endoscopic transphenoidal surgery note some degree of worsening in their sense of smell following surgery, a prospective multi-center study comparing the two techniques would provide impetus to pursue one strategy over another in order to maintain an important sense, olfaction. Through optimizing preservation of olfactory mucosa during endoscopic skull base surgeries, patients' likelihood of not detecting environmental hazards (e.g., smoke, gas, other poisonous materials) will be reduced and, equally as important, their quality of life would be improved.
- Conditions
- Pituitary Tumor, Surgery, Olfactory Nerve Injuries
- Being tested
- Electrocautery versus scalpel
- Medical subject headings
- Pituitary Neoplasms, Olfactory Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocautery versus scalpelProcedure or surgery
Electrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery group | Active comparator | Electrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery. Receives: Procedure: Electrocautery versus scalpel |
| Scalpel group | Active comparator | Scalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery. Receives: Procedure: Electrocautery versus scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in University of Pennsylvania Smell Identification Test (UPSIT)
Standardized and validated test of olfaction, which uses microencapsulated odorants released by scratching test booklets. Participants are asked to fill out forced choice multiple alternative questionnaires regarding each odorant. Minimum total score 0, maximum total score 40. Higher scores represent a better outcome.
Measured: Initial visit and at 1, 3 and 6-month follow-up visits
Change in Sniffin' Sticks
Validated 16-item odor identification test. Minimum total score 0, maximum total score 16. Higher scores represent better outcome.
Measured: Initial visit and at 1, 3 and 6-month follow-up visits
Change in Sino-Nasal Outcome Test-22 (SNOT-22)
Disease-specific, quality-of-life related measure of sinonasal function. Test consists of 22 symptoms requiring responders to rate severity on a 5-point Likert scale 0-5. Minimum score 0, maximum score 110. Higher scores correlate with greater rhinosinusitus-related health burden.
Measured: Initial visit and at 1, 3 and 6-month follow-up visits
Change in Skull Base Inventory (SBI)
Multidimensional, disease-specific instrument designed to measure quality of life of patients who undergo surgical treatment for anterior or central skull base pathologies. It covers several disease-specific domains including cognitive, endocrine, nasal, neurologic, visual, and other general areas.Each item is weighted equally in each domain score. Each domain is weighted equally in the overall score. Domain scores are calculated by taking the total score (sum of all items) in that domain divided by the maximum possible score for that domain multiplied by 100. The minimum score for each domain is 0 and the maximum is 100. The minimum score for the questionnaire is 0 and the maximum is 100. Higher score indicates better outcomes.
Measured: Initial visit and at 1, 3 and 6-month follow-up visits
Change in Pre-Op and Post-Op Endoscopy Scores
Used to quantify the pathological states of the nose and paranasal sinuses. Calculated on left and right side out, minimum 0, maximum 14. Higher scores indicate objectively worse sinonasal inflammation.
Measured: Initial visit and at 1, 3 and 6-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start25 Feb 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lee, Unity Health Toronto
- Investigators
- John Lee, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773705
- Sponsor's protocol ID
- 17-301
- Status last verified
- Mar 2019
- First submitted
- 19 Aug 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery: A Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03773705
- Acronym / sponsor ID
- 17-301
- Conditions
- Pituitary Tumor, Surgery, Olfactory Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Dec 2018 (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.
Pituitary tumours have an estimated prevalence of 20% in the general population and the number of clinically relevant pituitary adenomas is increasing with time. When symptomatic, the standard of care required for pituitary adenomas is resection through an endoscopic transsphenoidal approach. There is however significant olfactory dysfunction following endoscopic transsphenoidal pituitary surgery with approximately 23% of patients reporting some degree of worsening in their sense of smell in the postoperative period.
Pedicled nasoseptal flaps are used to repair skull base defects following resection of skull base tumours. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. The use of electrocautery in surgery has provided surgeons with greater hemostasis when compared to a scalpel. This is of utmost importance in many regions of the head \& neck where highly vascularized tissue results in difficulties achieving adequate hemostasis and therefore limiting view of the surgical field. However, the use of electrocautery increases thermal damage to surrounding tissue and impairs wound healing when compared to a scalpel.
Although the transmission of thermal energy via electrocautery to adjacent mucosa containing olfactory epithelium may theoretically contribute to olfactory disturbances, no prospective randomized controlled trials have yet examined the impact of these two different techniques on postoperative olfactory function. The purpose of this research study is to determine the effects, if any, of electrocautery versus scalpel on olfaction in raising the nasoseptal flap for repairing skull base defects following transphenoidal surgery.
Detailed description
Pedicled nasoseptal flaps are used to repair skull base defects following endoscopic transphenoidal surgery. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. While it is hypothesized that the olfactory mucosa is at greater risk of thermal injury with the use of electrocautery, no prospective multi-center studies have examined the impact of these two different techniques on postoperative olfactory function.
Patients will be recruited through the Otolaryngology-Head \& Neck Surgery clinics. Based on previous studies in a North American population, a 10% change in UPSIT score was considered to be significant. With an alpha error set to 0.05, a beta of 0.8 and an effect size of 1 standard deviation, a sample size of 20 was calculated.
After obtaining consent for enrolment into the study, each patient will undergo either: (1) electrocautery or (2) scalpel in the elevation of nasoseptal flaps based on primary surgeon preference. The University of Pennsylvania Smell Identification Test (UPSIT) will be used for baseline testing of olfactory function in all enrolled patients. Postoperatively, all enrolled patients will be seen in follow-up at 1, 3 and 6 months' time, at which point the UPSIT will be administered for testing of postoperative olfactory function.
The Wilcoxon signed-rank test will be used to determine differences between UPSIT scores pre- and postoperatively. Results of p<0.05 will be considered statistically significant. Linear regression will be used to examine relationships between UPSIT scores and other variables collected (e.g., demographic data, size/type of pituitary tumour, length of nasoseptal flap).
Given that approximately 23% of all patients who undergo endoscopic transphenoidal surgery note some degree of worsening in their sense of smell following surgery, a prospective multi-center study comparing the two techniques would provide impetus to pursue one strategy over another in order to maintain an important sense, olfaction. Through optimizing preservation of olfactory mucosa during endoscopic skull base surgeries, patients' likelihood of not detecting environmental hazards (e.g., smoke, gas, other poisonous materials) will be reduced and, equally as important, their quality of life would be improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery group | Active comparator | Procedure: Electrocautery versus scalpelElectrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery. |
| Scalpel group | Active comparator | Procedure: Electrocautery versus scalpelScalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age ≥18 years)
- Patients with tumours of the pituitary gland electively scheduled for endoscopic transsphenoidal surgery with nasoseptal flap coverage
Key exclusion criteria (8 listed)
- Documented evidence of sinonasal disease on either nasal endoscopy or radiography
- Patients with a clinical history of asthma and/or sinonasal disease
- Previous sinus surgery
- Previous skull base surgery
- History of pre-existing hyposmia or anosmia
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 |
|---|---|---|
| Electrocautery versus scalpelElectrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery | Procedure or surgery | Electrocautery group, Scalpel group |
Primary outcome
Change in University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: Initial visit and at 1, 3 and 6-month follow-up visits
Standardized and validated test of olfaction, which uses microencapsulated odorants released by scratching test booklets. Participants are asked to fill out forced choice multiple alternative questionnaires regarding each odorant. Minimum total score 0, maximum total score 40. Higher scores represent a better outcome.
Change in Sniffin' Sticks
Time frame: Initial visit and at 1, 3 and 6-month follow-up visits
Validated 16-item odor identification test. Minimum total score 0, maximum total score 16. Higher scores represent better outcome.
Change in Sino-Nasal Outcome Test-22 (SNOT-22)
Time frame: Initial visit and at 1, 3 and 6-month follow-up visits
Disease-specific, quality-of-life related measure of sinonasal function. Test consists of 22 symptoms requiring responders to rate severity on a 5-point Likert scale 0-5. Minimum score 0, maximum score 110. Higher scores correlate with greater rhinosinusitus-related health burden.
Change in Skull Base Inventory (SBI)
Time frame: Initial visit and at 1, 3 and 6-month follow-up visits
Multidimensional, disease-specific instrument designed to measure quality of life of patients who undergo surgical treatment for anterior or central skull base pathologies. It covers several disease-specific domains including cognitive, endocrine, nasal, neurologic, visual, and other general areas.Each item is weighted equally in each domain score. Each domain is weighted equally in the overall score. Domain scores are calculated by taking the total score (sum of all items) in that domain divided by the maximum possible score for that domain multiplied by 100. The minimum score for each domain is 0 and the maximum is 100. The minimum score for the questionnaire is 0 and the maximum is 100. Higher score indicates better outcomes.
Change in Pre-Op and Post-Op Endoscopy Scores
Time frame: Initial visit and at 1, 3 and 6-month follow-up visits
Used to quantify the pathological states of the nose and paranasal sinuses. Calculated on left and right side out, minimum 0, maximum 14. Higher scores indicate objectively worse sinonasal inflammation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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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.
John Lee, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocautery versus scalpel in people with Pituitary Tumor and Surgery, run by Unity Health Toronto at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 15 Mar 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Lee, MD (416-864-5306, leejo@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in University of Pennsylvania Smell Identification Test (UPSIT) (time frame: Initial visit and at 1, 3 and 6-month follow-up visits). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2019.