Prospective Quality of Life Study in Pituitary Surgery
- Conditions
- Post Operative CareEndoscopic Skull Base SurgeryPostoperative Period
- Interventions
- Other: Follow-up schedule
- Registration Number
- NCT03694990
- Lead Sponsor
- University of Virginia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 165
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Short-term Follow-up schedule Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery. Long-term Follow-up schedule Patients will be scheduled for PO follow-up visits 8 weeks after surgery. Intermediate Follow-up schedule Patients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery.
- Primary Outcome Measures
Name Time Method SNOT-22 survey scores for pre-op/initial visit 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 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 8-weeks post-op Patient responses to the SNOT-22 will be collected and calculated.
SNOT-22 survey scores for 3-month contact 3-month contact Patient responses to the SNOT-22 will be collected and calculated.
SNOT-22 survey scores for 6-month follow-up visit 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 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 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 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 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 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 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 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 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 6-month post-op 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 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 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 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 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 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 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 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 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 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 8-weeks post-op Patient responses to the Skull Based Inventory will be collected and calculated.
Skull Based Inventory scores for 3-month contact 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 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 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 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 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 6-month post-op Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.
- Secondary Outcome Measures
Name Time Method 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). 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 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 intraoperative Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used)