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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term | Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up schedule | Other | Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits. |
|
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Mattos, MD | Contact | 434-924-5934 | jm6cb@virginia.edu | |
| Karis Ra, BA | Contact | 703-399-6628 | hr6dz@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jose Mattos, MD | University of Virginia School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26614842 | Background | Tien DA, Stokken JK, Recinos PF, Woodard TD, Sindwani R. Comprehensive Postoperative Management After Endoscopic Skull Base Surgery. Otolaryngol Clin North Am. 2016 Feb;49(1):253-63. doi: 10.1016/j.otc.2015.09.015. | |
| 25496636 | Background | Nyquist GG, Rosen MR, Friedel ME, Beahm DD, Farrell CJ, Evans JJ. Comprehensive management of the paranasal sinuses in patients undergoing endoscopic endonasal skull base surgery. World Neurosurg. 2014 Dec;82(6 Suppl):S54-8. doi: 10.1016/j.wneu.2014.07.027. |
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| 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 |
| 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 |
| 22287366 | Background | Suberman TA, Zanation AM, Ewend MG, Senior BA, Ebert CS Jr. Sinonasal quality-of-life before and after endoscopic, endonasal, minimally invasive pituitary surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):161-6. doi: 10.1002/alr.20029. Epub 2011 Apr 26. |
| 25884256 | Background | Little AS, Kelly DF, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study. J Neurosurg. 2015 Sep;123(3):799-807. doi: 10.3171/2014.10.JNS14921. Epub 2015 Apr 17. |
| 26172128 | Background | Woodmansee WW, Carmichael J, Kelly D, Katznelson L; AACE Neuroendocrine and Pituitary Scientific Committee. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY DISEASE STATE CLINICAL REVIEW: POSTOPERATIVE MANAGEMENT FOLLOWING PITUITARY SURGERY. Endocr Pract. 2015 Jul;21(7):832-8. doi: 10.4158/EP14541.DSCR. |