Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor |
Other: Placebo training
Participants perform olfactory training using sticks filled with unscented medium chain triglycerides.
|
| Experimental: Treatment Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus) |
Other: Olfactory training
Participants perform olfactory training using sticks filled with scented essential oils.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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.
- 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English Speaking
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preoperative diagnosis of benign sellar or parasellar skull base pathology
Exclusion Criteria:
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preoperative diagnosis of malignant sellar or parasellar skull base pathology
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history of endoscopic sinus surgery
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history of skull base surgery
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history of radiation therapy or other local treatments for the management of facial, sinonasal, or cranial pathologies
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history of chronic rhinosinusitis
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history of neurocognitive disorder
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history of intrinsic chemosensory pathology
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history of cardiac pacemaker
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history of gastrectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Medicine | Baltimore | Maryland | United States | 21224 |
Sponsors and Collaborators
- Johns Hopkins University
- North American Skull Base Society
Investigators
- Principal Investigator: Nicholas Rowan, MD, Johns Hopkins School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00311777