Status:
UNKNOWN
Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery
Lead Sponsor:
Unity Health Toronto
Conditions:
Pituitary Tumor
Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 fl...
Eligibility Criteria
Inclusion
- Adult patients (age ≥18 years)
- Patients with tumours of the pituitary gland electively scheduled for endoscopic transsphenoidal surgery with nasoseptal flap coverage
Exclusion
- 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
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03773705
Start Date
February 25 2019
End Date
December 31 2019
Last Update
March 15 2019
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8