Prospective Quality of Life Study in Pituitary Surgery

赞助:

合作者:

信息的提供 (责任方):

Jose Mattos, MD，University of Virginia

追踪信息

首次提交日期 ^ICMJE

September 26, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

SNOT-22 survey scores for pre-op/initial visit[ Time Frame: 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[ Time Frame: 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[ Time Frame: 8-weeks post-op ]

Patient responses to the SNOT-22 will be collected and calculated.

SNOT-22 survey scores for 3-month contact[ Time Frame: 3-month contact ]

Patient responses to the SNOT-22 will be collected and calculated.

SNOT-22 survey scores for 6-month follow-up visit[ Time Frame: 6-month post-op ]

Patient responses to the SNOT-22 will be collected and calculated.

Anterior Skull Base QOL survey scores for pre-op/initial visit[ Time Frame: 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[ Time Frame: 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 8-week follow-up visit[ Time Frame: 8-weeks post-op ]

Patient responses to the Anterior Skull Base QOL will be collected and calculated.

Anterior Skull Base QOL survey scores for 3-month contact[ Time Frame: 3-month contact ]

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[ Time Frame: 6-month 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[ Time Frame: 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[ Time Frame: 2-weeks or 4-weeks after surgery (based on group) ]

Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.

Pain Catastrophizing Scale (PCS) response for 8-week follow-up visit[ Time Frame: 8-weeks post-op ]

Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.

Pain Catastrophizing Scale (PCS) response for 3-month contact[ Time Frame: 3-month contact ]

Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.

Pain Catastrophizing Scale (PCS) response for 6-month follow-up visit[ Time Frame: 6-month post-op ]

Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated.

Questionnaire of Olfactory Disorders survey scores for pre-op/initial visit[ Time Frame: 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[ Time Frame: 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 8-week follow-up visit[ Time Frame: 8-weeks post-op ]

Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated.

Questionnaire of Olfactory Disorders survey scores for 3-month contact[ Time Frame: 3-month contact ]

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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 8-weeks post-op ]

Patient responses to the Skull Based Inventory will be collected and calculated.

Skull Based Inventory scores for 3-month contact[ Time Frame: 3-month contact ]

Patient responses to the Skull Based Inventory will be collected and calculated.

Skull Based Inventory scores for 6-month follow-up visit[ Time Frame: 6-month post-op ]

Patient responses to the Skull Based Inventory will be collected and calculated.

Quality of Recover (QOR 40) survey scores for pre-op/initial visit[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 6-month post-op ]

Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Physician's notes/Patient progress notes for patient clinic visits[ Time Frame: 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). ]
Notes taken by the physician/medical staff during subject's clinic visit (i.e. lesion pathology, cavernous sinus invasion, suprasellar extension, post-op assessment, presence of nasal synechiae, rate of medpor graft extrusion)
Endoscopy scores[ Time Frame: 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). ]
Lund-Kennedy scoring of endoscopic imaging of nasal cavity
Surgery notes/outcomes[ Time Frame: intraoperative ]
Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used)

描述性信息

简略标题 ^ICMJE

Prospective Quality of Life Study in Pituitary Surgery

正式标题 ^ICMJE

Prospective Quality of Life Study in Pituitary Surgery

简要概况

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.

详细说明

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Follow-up schedule
Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.

研究工具

: Short-term
Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery.
: Intermediate
Patients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery.
: Long-term
Patients will be scheduled for PO follow-up visits 8 weeks after surgery.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

165

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2020

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Prisoner

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

Jose Mattos, MD，University of Virginia

研究赞助商 ^ICMJE

University of Virginia

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Jose Mattos, MD University of Virginia School of Medicine

PRS 账户

University of Virginia

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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