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

NCT03773705 | Unknown

• 1 other identifier: 17-301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor; Surgery; Olfactory Nerve Injuries

Outcome Measures

Primary Outcomes (5)

• Change in University of Pennsylvania Smell Identification Test (UPSIT)

  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.

  Initial visit and at 1, 3 and 6-month follow-up visits

• Change in Sniffin' Sticks

  Validated 16-item odor identification test. Minimum total score 0, maximum total score 16. Higher scores represent better outcome.

  Initial visit and at 1, 3 and 6-month follow-up visits

• Change in Sino-Nasal Outcome Test-22 (SNOT-22)

  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.

  Initial visit and at 1, 3 and 6-month follow-up visits

• Change in Skull Base Inventory (SBI)

  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.

  Initial visit and at 1, 3 and 6-month follow-up visits

• Change in Pre-Op and Post-Op Endoscopy Scores

  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.

  Initial visit and at 1, 3 and 6-month follow-up visits

Study Arms (2)

Electrocautery group

ACTIVE COMPARATOR

Electrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.

Procedure: Electrocautery versus scalpel

Scalpel group

ACTIVE COMPARATOR

Scalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.

Procedure: Electrocautery versus scalpel

Interventions

Electrocautery versus scalpel PROCEDURE

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

Electrocautery group; Scalpel group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms; Olfactory Nerve Injuries

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Olfactory Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• John Lee, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Lee, MD

CONTACT

416-864-5306; leejo@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Rhinology, Principal Investigator

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: December 12, 2018
• Study Start: February 25, 2019
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

CA (1)