Prospective Quality of Life Study in Pituitary Surgery

Study Overview
=================
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.

Official Title
-----------------
Prospective Quality of Life Study in Pituitary Surgery

Conditions
-----------------
Post Operative Care, Endoscopic Skull Base Surgery, Postoperative Period

Intervention / Treatment
-----------------
* Other: Follow-up schedule


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Short-term<br>Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery. | Other: Follow-up schedule<br>* Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.<br>|
| Intermediate<br>Patients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery. | Other: Follow-up schedule<br>* Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.<br>|
| Long-term<br>Patients will be scheduled for PO follow-up visits 8 weeks after surgery. | Other: Follow-up schedule<br>* Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-22 survey scores for pre-op/initial visit | Patient responses to the SNOT-22 will be collected and calculated. | Survey results will be collected during the pre-op/initial 1 day visit | 
| SNOT-22 survey scores for 2-week or 4-week follow-up visit | Patient responses to the SNOT-22 will be collected and calculated. | 2-weeks or 4-weeks after surgery (based on group) | 
| SNOT-22 survey scores for 8-week follow-up visit | Patient responses to the SNOT-22 will be collected and calculated. | 8-weeks post-op | 
| SNOT-22 survey scores for 3-month contact | Patient responses to the SNOT-22 will be collected and calculated. | 3-month contact | 
| SNOT-22 survey scores for 6-month follow-up visit | Patient responses to the SNOT-22 will be collected and calculated. | 6-month post-op | 
| Anterior Skull Base QOL survey scores for pre-op/initial visit | Patient responses to the Anterior Skull Base QOL will be collected and calculated. | collected during the pre-op/initial 1 day visit | 
| Anterior Skull Base QOL survey scores for 2-week or 4-week follow-up visit | Patient responses to the Anterior Skull Base QOL will be collected and calculated. | 2-weeks or 4-weeks after surgery (based on group) | 
| Anterior Skull Base QOL survey scores for 8-week follow-up visit | Patient responses to the Anterior Skull Base QOL will be collected and calculated. | 8-weeks post-op | 
| Anterior Skull Base QOL survey scores for 3-month contact | Patient responses to the Anterior Skull Base QOL will be collected and calculated. | 3-month contact | 
| Anterior Skull Base QOL survey scores for 6-month follow-up visit | Patient responses to the Anterior Skull Base QOL will be collected and calculated. | 6-month post-op | 
| Pain Catastrophizing Scale (PCS) response for pre-op/initial visit | Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated. | collected during the pre-op/initial 1 day visit | 
| Pain Catastrophizing Scale (PCS) response for 2-week or 4-week follow-up visit | Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated. | 2-weeks or 4-weeks after surgery (based on group) | 
| Pain Catastrophizing Scale (PCS) response for 8-week follow-up visit | Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated. | 8-weeks post-op | 
| Pain Catastrophizing Scale (PCS) response for 3-month contact | Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated. | 3-month contact | 
| Pain Catastrophizing Scale (PCS) response for 6-month follow-up visit | Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated. | 6-month post-op | 
| Questionnaire of Olfactory Disorders survey scores for pre-op/initial visit | Patient responses to the Pain Catastrophizing Scale (PCS) will be collected and calculated. | collected during the pre-op/initial 1 day visit | 
| Questionnaire of Olfactory Disorders survey scores for 2-week or 4-week follow-up visit | Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated. | 2-weeks or 4-weeks after surgery (based on group) | 
| Questionnaire of Olfactory Disorders survey scores for 8-week follow-up visit | Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated. | 8-weeks post-op | 
| Questionnaire of Olfactory Disorders survey scores for 3-month contact | Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated. | 3-month contact | 
| Questionnaire of Olfactory Disorders survey scores for 6-month follow-up visit | Patient responses to the Questionnaire of Olfactory Disorders will be collected and calculated. | 6-month post-op | 
| Skull Based Inventory scores for pre-op/initial visit | Patient responses to the Skull Based Inventory will be collected and calculated. | collected during the pre-op/initial 1 day visit | 
| Skull Based Inventory scores for 2-week or 4-week follow-up visit | Patient responses to the Skull Based Inventory will be collected and calculated. | 2-weeks or 4-weeks after surgery (based on group) | 
| Skull Based Inventory scores for 8-week follow-up visit | Patient responses to the Skull Based Inventory will be collected and calculated. | 8-weeks post-op | 
| Skull Based Inventory scores for 3-month contact | Patient responses to the Skull Based Inventory will be collected and calculated. | 3-month contact | 
| Skull Based Inventory scores for 6-month follow-up visit | Patient responses to the Skull Based Inventory will be collected and calculated. | 6-month post-op | 
| Quality of Recover (QOR 40) survey scores for pre-op/initial visit | Patient responses to the Quality of Recover (QOR 40) will be collected and calculated. | collected during the pre-op/initial 1 day visit | 
| Quality of Recover (QOR 40) survey scores for 2-week or 4-week follow-up visit | Patient responses to the Quality of Recover (QOR 40) will be collected and calculated. | 2-weeks or 4-weeks after surgery (based on group) | 
| Quality of Recover (QOR 40) survey scores for 8-week follow-up visit | Patient responses to the Quality of Recover (QOR 40) will be collected and calculated. | 8-weeks post-op | 
| Quality of Recover (QOR 40) survey scores for 3-month contact | Patient responses to the Quality of Recover (QOR 40) will be collected and calculated. | 3-month contact | 
| Quality of Recover (QOR 40) survey scores for 6-month follow-up visit | Patient responses to the Quality of Recover (QOR 40) will be collected and calculated. | 6-month post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's notes/Patient progress notes for patient clinic visits | 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) | 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 | Lund-Kennedy scoring of endoscopic imaging of nasal cavity | 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 | Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used) | intraoperative |