Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Quality of Life Study in Pituitary Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694990
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jose Mattos, MD, University of Virginia

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.

Condition or disease Intervention/treatment
Post Operative Care Endoscopic Skull Base Surgery Postoperative Period Other: Follow-up schedule

Layout table for study information
Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Quality of Life Study in Pituitary Surgery
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. SNOT-22 survey scores for 3-month contact [ Time Frame: 3-month contact ]
    Patient responses to the SNOT-22 will be collected and calculated.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Surgery notes/outcomes [ Time Frame: intraoperative ]
    Surgeon's notes on subject surgery (i.e. occurrence of intra-operative leak, type of packing used)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694990


Contacts
Layout table for location contacts
Contact: Jose Mattos, MD 434-924-5934 jm6cb@virginia.edu
Contact: Karis Ra, BA 703-399-6628 hr6dz@virginia.edu

Sponsors and Collaborators
University of Virginia
Investigators
Layout table for investigator information
Principal Investigator: Jose Mattos, MD University of Virginia School of Medicine

Publications:

Layout table for additonal information
Responsible Party: Jose Mattos, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03694990     History of Changes
Other Study ID Numbers: 20758
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No