An observational study in Post Operative Care, Endoscopic Skull Base Surgery and Postoperative Period, sponsored by University of Virginia. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by University of Virginia · Observational
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.
University of Virginia is the lead sponsor of 673 studies on the registry; 139 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery.
Other: Follow-up schedule
Patients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery.
Other: Follow-up schedule
Patients will be scheduled for PO follow-up visits 8 weeks after surgery.
Other: Follow-up schedule
Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.
SNOT-22 survey scores for pre-op/initial visit
Patient responses to the SNOT-22 will be collected and calculated.
Time frame: 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.
Time frame: 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.
Time frame: 8-weeks post-op
SNOT-22 survey scores for 3-month contact
Patient responses to the SNOT-22 will be collected and calculated.
Time frame: 3-month contact
SNOT-22 survey scores for 6-month follow-up visit
Patient responses to the SNOT-22 will be collected and calculated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8-weeks post-op
Skull Based Inventory scores for 3-month contact
Patient responses to the Skull Based Inventory will be collected and calculated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-month post-op
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)
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).
Endoscopy scores
Lund-Kennedy scoring of endoscopic imaging of nasal cavity
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).
Surgery notes/outcomes
Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used)
Time frame: intraoperative
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Oct 2018; primary completion for Oct 2020, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.