Endoscopic Skull Base Surgery, Post Operative Care, Postoperative Period
Conditions
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.
Interventions
OTHERFollow-up schedule
Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.
Sponsors
University of Virginia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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 8-week follow-up visit | 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 | 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 | 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 | 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 3-month contact | 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 | 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 | 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 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Contacts
Primary ContactJose Mattos, MD
Backup ContactKaris Ra, BA
Outcome results
None listed