Post Operative CareNCT03694990
Prospective Quality of Life Study in Pituitary Surgery
An observational study of Post Operative Care and Endoscopic Skull Base Surgery, run by University of Virginia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Care, Endoscopic Skull Base Surgery, Postoperative Period
- What is being tested?
- Follow-up schedule
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Follow-up schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up scheduleOther
Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Short-term | Patients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery. Receives: Other: Follow-up schedule | |
| Intermediate | Patients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery. Receives: Other: Follow-up schedule | |
| Long-term | Patients will be scheduled for PO follow-up visits 8 weeks after surgery. Receives: Other: Follow-up schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-22 survey scores for pre-op/initial visit
Patient responses to the SNOT-22 will be collected and calculated.
Measured: 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.
Measured: 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.
Measured: 8-weeks post-op
SNOT-22 survey scores for 3-month contact
Patient responses to the SNOT-22 will be collected and calculated.
Measured: 3-month contact
SNOT-22 survey scores for 6-month follow-up visit
Patient responses to the SNOT-22 will be collected and calculated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8-weeks post-op
Skull Based Inventory scores for 3-month contact
Patient responses to the Skull Based Inventory will be collected and calculated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-month post-op
Secondary outcomes (3)
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)
Measured: 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
Measured: 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)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Operative CareStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Mattos, MD, University of Virginia
- Investigators
- Jose Mattos, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694990
- Sponsor's protocol ID
- 20758
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26614842Nyquist 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.
PubMed 25496636Suberman 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.
PubMed 22287366Little 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.
PubMed 25884256Woodmansee 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.
PubMed 26172128
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Quality of Life Study in Pituitary Surgery
- ClinicalTrials.gov ID
- NCT03694990
- Acronym / sponsor ID
- 20758
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short-term | – | Other: Follow-up schedulePatients will be scheduled for PO follow-up visits 2 weeks, and 8 weeks after surgery. |
| Intermediate | – | Other: Follow-up schedulePatients will be scheduled for PO follow-up visits 4 weeks, and 8 weeks after surgery. |
| Long-term | – | Other: Follow-up schedulePatients will be scheduled for PO follow-up visits 8 weeks after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving surgery for pituitary adenoma at UVA after May 1st, 2018.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Extended approaches
- Use of naso-septal flap during the current surgical procedure
- Septoplasty
- Prior history of Chronic Rhinosinusitis (CRS)
- Prior history of sphenoidotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up schedulePatients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits. | Other | Intermediate, Long-term, Short-term |
Primary outcome
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.
3 secondary outcomes
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).
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).
Surgery notes/outcomes
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 26614842Tien 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.
- Background: PubMed 25496636Nyquist 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.
- Background: PubMed 22287366Suberman 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.
- Background: PubMed 25884256Little 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.
- Background: PubMed 26172128Woodmansee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Mattos, MD principal investigator
University of Virginia School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Care and Endoscopic Skull Base Surgery, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Mattos, MD (434-924-5934, jm6cb@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNOT-22 survey scores for pre-op/initial visit (time frame: Survey results will be collected during the pre-op/initial 1 day visit). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694990, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.