Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

Not Applicable

Recruiting

• Conditions: Anosmia; Skull Base Neoplasms
• Interventions: Other: Placebo training; Other: Olfactory training

• Registration Number: NCT05912881
• Lead Sponsor: Johns Hopkins University

Brief Summary

The investigators hypothesize that patients undergoing endoscopic endonasal skull base surgery experience clinically meaningful and modifiable disruptions in postoperative chemosensory function and quality of life, and the investigators further hypothesize that olfactory training in the postoperative period may significantly hasten normalization of patients' chemosensory perturbations. This tailored prospective study seeks to fulfill a significant gap in the understanding of the characteristics, implications, and treatment options for postoperative olfactory and gustatory impairment following endoscopic endonasal skull base surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• English Speaking
• preoperative diagnosis of benign sellar or parasellar skull base pathology

Exclusion Criteria

• preoperative diagnosis of malignant sellar or parasellar skull base pathology
• history of endoscopic sinus surgery
• history of skull base surgery
• history of radiation therapy or other local treatments for the management of facial, sinonasal, or cranial pathologies
• history of chronic rhinosinusitis
• history of neurocognitive disorder
• history of intrinsic chemosensory pathology
• history of cardiac pacemaker
• history of gastrectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo training	Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor
Treatment	Olfactory training	Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus)

Primary Outcome Measures

Name	Time	Method
Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit	Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative	Olfactory function as determined using the commercially available "Sniffin' Sticks" olfactory testing kit. Olfactory function is tested in three domains: threshold, discrimination, and identification. For threshold testing, the most dilute concentration of odorant that the participant is able to reliably detect is determined. In discrimination testing, the participant is evaluated on their ability to discern the unique scent among three scented sticks. In identification testing, the patient names the smells using a multiple choice form which offers four definitions for every Sniffin' stick, only one of which is correct.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of smell and taste as assessed by a Visual analog scale	Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative	Quality of smell and taste as indicated on a visual analog scale. Score range 0-100, where higher score is better and indicative of better smell and taste function.
Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12	Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative	Quality of life questionnaire. Score range 0-60, where higher score is worse and indicates more onerous symptoms.
Change in Quality of Life as assessed by the Skull Base Inventory	Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative	Quality of life questionnaire. Score range 0-100, where higher score is better, indicative of less burden on quality of life.
Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire	Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative	Quality of life questionnaire. Score range 0-112, where higher score is worse and indicates greater degree of olfactory dysfunction.

Trial Locations

Locations (1)

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States