Surgery Clinical Trial
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.
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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