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

NCT03773705 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-15

No results posted yet for this 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.

Conditions

  • Pituitary Tumor
  • Surgery
  • Olfactory Nerve Injuries

Interventions

PROCEDURE

Electrocautery versus scalpel

Electrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • John Lee, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03773705 on ClinicalTrials.gov