Clinical trial NCT05912881: Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
Official title: Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anosmia
Skull Base Neoplasms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: North American Skull Base Society
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are enrolled into treatment or placebo groups for the entirety of the study.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit
timeFrame: Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative
Secondary outcomes:
measure: Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12
timeFrame: Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
measure: Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire
timeFrame: Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
measure: Change in Quality of Life as assessed by the Skull Base Inventory
timeFrame: Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
measure: Change in Quality of smell and taste as assessed by a Visual analog scale
timeFrame: Pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Nicholas Rowan, MD
role: PRINCIPAL_INVESTIGATOR
References: