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Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery

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ClinicalTrials.gov Identifier: NCT03773705
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
John Lee, St. Michael's Hospital, Toronto

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Pituitary Tumor Surgery Olfactory Nerve Injuries Procedure: Electrocautery versus scalpel Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery: A Single-blinded Randomized Controlled Trial
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Electrocautery group
Electrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.
Procedure: Electrocautery versus scalpel
Electrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery

Active Comparator: Scalpel group
Scalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.
Procedure: Electrocautery versus scalpel
Electrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age ≥18 years)
  • Patients with tumours of the pituitary gland electively scheduled for endoscopic transsphenoidal surgery with nasoseptal flap coverage

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773705


Contacts
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Contact: John Lee, MD 416-864-5306 leejo@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Andrea Figol, MSc    416-864-6060 ext 6591    FigolA@smh.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: John Lee, MD St. Michael's Hospital, Toronto

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Responsible Party: John Lee, Head, Division of Rhinology, Principal Investigator, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03773705     History of Changes
Other Study ID Numbers: 17-301
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Olfactory Nerve Injuries
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Cranial Nerve Injuries
Cranial Nerve Diseases
Olfactory Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries