Prospective Quality of Life Study in Pituitary Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 主要终点
- SNOT-22 survey scores for pre-op/initial visit
研究概览
简要总结
Post-operative assessment and debridement are key components in patient care for surgery patients. However, a standardized protocol for management after endoscopic skull base surgery is unavailable. In this study, investigators will observe the effect of various follow-up schedules on the patient's quality of life after surgery. Patients who received surgery for pituitary adenoma will be placed randomly in 1 of 3 groups (short-term = follow-up in 2 weeks and 8 weeks after surgery; intermediate = 4 weeks and 8 weeks; long-term = 8 weeks). At each visit, patients will be asked to complete a packet of surveys and questionnaires that provide metrics on their quality of life in addition to receiving standard patient care (post-operative assessment and nasal debridement). Researchers hope to find that a follow-up schedule that has patients visiting the clinic closer to their surgery date will increase the patient's quality of life after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has surgery for pituitary adenoma at UVA after May 1st, 2018
- •Has sellar and parasellar pathology
- •≥ 18 years old
- •Can complete all parts of study in English
排除标准
- •Extended approaches
- •Use of naso-septal flap during the current surgical procedure
- •Septoplasty
- •Prior history of Chronic Rhinosinusitis (CRS)
- •Prior history of sphenoidotomy
- •< 18 years old
结局指标
主要结局
SNOT-22 survey scores for pre-op/initial visit
时间窗: Survey results will be collected during the pre-op/initial 1 day visit
Patient responses to the SNOT-22 will be collected and calculated.
SNOT-22 survey scores for 2-week or 4-week follow-up visit
时间窗: 2-weeks or 4-weeks after surgery (based on group)
Patient responses to the SNOT-22 will be collected and calculated.
SNOT-22 survey scores for 8-week follow-up visit
时间窗: 8-weeks post-op
Patient responses to the SNOT-22 will be collected and calculated.
SNOT-22 survey scores for 3-month contact
时间窗: 3-month contact
Patient responses to the SNOT-22 will be collected and calculated.
SNOT-22 survey scores for 6-month follow-up visit
时间窗: 6-month post-op
Patient responses to the SNOT-22 will be collected and calculated.
Anterior Skull Base QOL survey scores for 3-month contact
时间窗: 3-month contact
Patient responses to the Anterior Skull Base QOL will be collected and calculated.
Anterior Skull Base QOL survey scores for pre-op/initial visit
时间窗: collected during the pre-op/initial 1 day visit
Patient responses to the Anterior Skull Base QOL will be collected and calculated.
Anterior Skull Base QOL survey scores for 2-week or 4-week follow-up visit
时间窗: 2-weeks or 4-weeks after surgery (based on group)
Patient responses to the Anterior Skull Base QOL will be collected and calculated.
Anterior Skull Base QOL survey scores for 6-month follow-up visit
时间窗: 6-month post-op
Patient responses to the Anterior Skull Base QOL will be collected and calculated.
Anterior Skull Base QOL survey scores for 8-week follow-up visit
时间窗: 8-weeks post-op
Patient responses to the Anterior Skull Base QOL will be collected and calculated.
Pain Catastrophizing Scale (PCS) response for pre-op/initial visit
时间窗: collected during the pre-op/initial 1 day visit
Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.
Pain Catastrophizing Scale (PCS) response for 2-week or 4-week follow-up visit
时间窗: 2-weeks or 4-weeks after surgery (based on group)
Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.
Questionnaire of Olfactory Disorders survey scores for 8-week follow-up visit
时间窗: 8-weeks post-op
Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated.
Pain Catastrophizing Scale (PCS) response for 8-week follow-up visit
时间窗: 8-weeks post-op
Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.
Pain Catastrophizing Scale (PCS) response for 6-month follow-up visit
时间窗: 6-month post-op
Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.
Questionnaire of Olfactory Disorders survey scores for 3-month contact
时间窗: 3-month contact
Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated.
Skull Based Inventory scores for 6-month follow-up visit
时间窗: 6-month post-op
Patient responses to the Skull Based Inventory will be collected and calculated.
Pain Catastrophizing Scale (PCS) response for 3-month contact
时间窗: 3-month contact
Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.
Questionnaire of Olfactory Disorders survey scores for pre-op/initial visit
时间窗: collected during the pre-op/initial 1 day visit
Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.
Questionnaire of Olfactory Disorders survey scores for 2-week or 4-week follow-up visit
时间窗: 2-weeks or 4-weeks after surgery (based on group)
Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated.
Questionnaire of Olfactory Disorders survey scores for 6-month follow-up visit
时间窗: 6-month post-op
Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated.
Skull Based Inventory scores for pre-op/initial visit
时间窗: collected during the pre-op/initial 1 day visit
Patient responses to the Skull Based Inventory will be collected and calculated.
Skull Based Inventory scores for 2-week or 4-week follow-up visit
时间窗: 2-weeks or 4-weeks after surgery (based on group)
Patient responses to the Skull Based Inventory will be collected and calculated.
Skull Based Inventory scores for 8-week follow-up visit
时间窗: 8-weeks post-op
Patient responses to the Skull Based Inventory will be collected and calculated.
Skull Based Inventory scores for 3-month contact
时间窗: 3-month contact
Patient responses to the Skull Based Inventory will be collected and calculated.
Quality of Recover (QOR 40) survey scores for pre-op/initial visit
时间窗: collected during the pre-op/initial 1 day visit
Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.
Quality of Recover (QOR 40) survey scores for 2-week or 4-week follow-up visit
时间窗: 2-weeks or 4-weeks after surgery (based on group)
Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.
Quality of Recover (QOR 40) survey scores for 8-week follow-up visit
时间窗: 8-weeks post-op
Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.
Quality of Recover (QOR 40) survey scores for 3-month contact
时间窗: 3-month contact
Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.
Quality of Recover (QOR 40) survey scores for 6-month follow-up visit
时间窗: 6-month post-op
Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.
次要结局
- Physician's notes/Patient progress notes for patient clinic visits(Clinic visit notes and/or patient progress notes will be collected during the pre-op/initial 1 day visit, subsequent follow-up visits (2-weeks, 4-weeks, and 8-weeks post-op), and final visit (6-months post-op).)
- Endoscopy scores(Endoscopy scores will be collected during the pre-op/initial 1 day visit, subsequent follow-up visits (2-weeks, 4-weeks, and 8-weeks post-op), and final visit (6-months post-op).)
- Surgery notes/outcomes(intraoperative)
研究者
Jose Mattos, MD
Principal Investigator
University of Virginia