Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study team members and study participants are blinded as to which olfactory training kit (treatment vs placebo) the participants received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English Speaking
- •preoperative diagnosis of benign sellar or parasellar skull base pathology
排除标准
- •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
研究组 & 干预措施
Placebo
Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor
干预措施: Placebo training (Other)
Treatment
Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus)
干预措施: Olfactory training (Other)
结局指标
主要结局
Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)