Clinical trial NCT03694990: Prospective Quality of Life Study in Pituitary Surgery
Official title: Prospective Quality of Life Study in Pituitary Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Operative Care
Endoscopic Skull Base Surgery
Postoperative Period
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.

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.


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

Primary outcomes:
measure: SNOT-22 survey scores for pre-op/initial visit
timeFrame: Survey results will be collected during the pre-op/initial 1 day visit
measure: SNOT-22 survey scores for 2-week or 4-week follow-up visit
timeFrame: 2-weeks or 4-weeks after surgery (based on group)
measure: SNOT-22 survey scores for 8-week follow-up visit
timeFrame: 8-weeks post-op
measure: SNOT-22 survey scores for 3-month contact
timeFrame: 3-month contact
measure: SNOT-22 survey scores for 6-month follow-up visit
timeFrame: 6-month post-op
measure: Anterior Skull Base QOL survey scores for pre-op/initial visit
timeFrame: collected during the pre-op/initial 1 day visit
measure: Anterior Skull Base QOL survey scores for 2-week or 4-week follow-up visit
timeFrame: 2-weeks or 4-weeks after surgery (based on group)
measure: Anterior Skull Base QOL survey scores for 8-week follow-up visit
timeFrame: 8-weeks post-op
measure: Anterior Skull Base QOL survey scores for 3-month contact
timeFrame: 3-month contact
measure: Anterior Skull Base QOL survey scores for 6-month follow-up visit
timeFrame: 6-month post-op
measure: Pain Catastrophizing Scale (PCS) response for pre-op/initial visit
timeFrame: collected during the pre-op/initial 1 day visit
measure: Pain Catastrophizing Scale (PCS) response for 2-week or 4-week follow-up visit
timeFrame: 2-weeks or 4-weeks after surgery (based on group)
measure: Pain Catastrophizing Scale (PCS) response for 8-week follow-up visit
timeFrame: 8-weeks post-op
measure: Pain Catastrophizing Scale (PCS) response for 3-month contact
timeFrame: 3-month contact
measure: Pain Catastrophizing Scale (PCS) response for 6-month follow-up visit
timeFrame: 6-month post-op
measure: Questionnaire of Olfactory Disorders survey scores for pre-op/initial visit
timeFrame: collected during the pre-op/initial 1 day visit
measure: Questionnaire of Olfactory Disorders survey scores for 2-week or 4-week follow-up visit
timeFrame: 2-weeks or 4-weeks after surgery (based on group)
measure: Questionnaire of Olfactory Disorders survey scores for 8-week follow-up visit
timeFrame: 8-weeks post-op
measure: Questionnaire of Olfactory Disorders survey scores for 3-month contact
timeFrame: 3-month contact
measure: Questionnaire of Olfactory Disorders survey scores for 6-month follow-up visit
timeFrame: 6-month post-op
measure: Skull Based Inventory scores for pre-op/initial visit
timeFrame: collected during the pre-op/initial 1 day visit
measure: Skull Based Inventory scores for 2-week or 4-week follow-up visit
timeFrame: 2-weeks or 4-weeks after surgery (based on group)
measure: Skull Based Inventory scores for 8-week follow-up visit
timeFrame: 8-weeks post-op
measure: Skull Based Inventory scores for 3-month contact
timeFrame: 3-month contact
measure: Skull Based Inventory scores for 6-month follow-up visit
timeFrame: 6-month post-op
measure: Quality of Recover (QOR 40) survey scores for pre-op/initial visit
timeFrame: collected during the pre-op/initial 1 day visit
measure: Quality of Recover (QOR 40) survey scores for 2-week or 4-week follow-up visit
timeFrame: 2-weeks or 4-weeks after surgery (based on group)
measure: Quality of Recover (QOR 40) survey scores for 8-week follow-up visit
timeFrame: 8-weeks post-op
measure: Quality of Recover (QOR 40) survey scores for 3-month contact
timeFrame: 3-month contact
measure: Quality of Recover (QOR 40) survey scores for 6-month follow-up visit
timeFrame: 6-month post-op
Secondary outcomes:
measure: Physician's notes/Patient progress notes for patient clinic visits
timeFrame: 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).
measure: Endoscopy scores
timeFrame: 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).
measure: Surgery notes/outcomes
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia School of Medicine
name: Jose Mattos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.