← Back to Search

Procedure

Electrocautery group for Pituitary Tumors

N/A
Waitlist Available
Led By John Lee, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial visit and at 1, 3 and 6-month follow-up visits
Awards & highlights

Study 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.

Eligible Conditions
  • Pituitary Tumors
  • Surgery
  • Olfactory Nerve Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial visit and at 1, 3 and 6-month follow-up visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and initial visit and at 1, 3 and 6-month follow-up visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pre-Op and Post-Op Endoscopy Scores
Change in Sino-Nasal Outcome Test-22 (SNOT-22)
Change in Skull Base Inventory (SBI)
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Electrocautery groupActive Control1 Intervention
Electrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.
Group II: Scalpel groupActive Control1 Intervention
Scalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
540 Previous Clinical Trials
447,760 Total Patients Enrolled
John Lee, MDPrincipal InvestigatorUnity Health Toronto
1 Previous Clinical Trials
336 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby May 2025