Prospective Quality of Life Study in Pituitary Surgery

Postoperative Period Clinical Trial

Official title:

Prospective Quality of Life Study in Pituitary Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03694990
• Other study ID #: 20758
• Status: Not yet recruiting
• Start date: October 2018
• Est. completion date: October 2020

Study information

• Verified date: October 2018
• Source: University of Virginia
• Contact: Jose Mattos, MD
• Phone: 434-924-5934
• Email: jm6cb[@]virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Skull Base Surgery
• Post Operative Care
• Postoperative Period

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	SNOT-22 survey scores for 3-month contact	Patient responses to the SNOT-22 will be collected and calculated.	3-month contact
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	Skull Based Inventory scores for 3-month contact	Patient responses to the Skull Based Inventory will be collected and calculated.	3-month contact
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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	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).
Secondary	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).
Secondary	Surgery notes/outcomes	Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used)	intraoperative