Prospective Quality of Life Study in Pituitary Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Period; Post Operative Care; Endoscopic Skull Base Surgery
• Intervention / Treatment: Other: Follow-up schedule

• Study Type: Observational
• Enrollment (Anticipated): 165

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Jose Mattos, MD, University of Virginia School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No