Prospective Quality of Life Study in Pituitary Surgery

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jose Mattos, MD，University of Virginia

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

SNOT-22 survey scores for pre-op/initial visit[ Time Frame: 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[ Time Frame: 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[ Time Frame: 8-weeks post-op ]

Patient responses to the SNOT-22 will be collected and calculated.

SNOT-22 survey scores for 3-month contact[ Time Frame: 3-month contact ]

Patient responses to the SNOT-22 will be collected and calculated.

SNOT-22 survey scores for 6-month follow-up visit[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 8-weeks post-op ]

Patient responses to the Skull Based Inventory will be collected and calculated.

Skull Based Inventory scores for 3-month contact[ Time Frame: 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[ Time Frame: 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[ Time Frame: collected during the pre-op/initial 1 day visit ]

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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 3-month contact ]

Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.

Quality of Recover (QOR 40) survey scores for 6-month follow-up visit[ Time Frame: 6-month post-op ]

Patient responses to the Quality of Recover (QOR 40) will be collected and calculated.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Physician's notes/Patient progress notes for patient clinic visits[ 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). ]
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)
Endoscopy scores[ 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). ]
Lund-Kennedy scoring of endoscopic imaging of nasal cavity
Surgery notes/outcomes[ Time Frame: intraoperative ]
Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used)

Descriptive Information

Brief Title ^ICMJE

Prospective Quality of Life Study in Pituitary Surgery

Official Title ^ICMJE

Prospective Quality of Life Study in Pituitary Surgery

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.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: Follow-up schedule
Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.

Study Arms

: Short-term
Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery.
: 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

165

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2020

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Jose Mattos, MD，University of Virginia

Study Sponsor ^ICMJE

University of Virginia

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

University of Virginia

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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