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This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience (i.e. resident, fellow, attending), and choice of surgical equipment affect these forces. This information may be used to reduce these forces and prevent these issues from happening during certain laryngeal surgeries.
For the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively.
For the next 50 patients, surgeons will be given force measurements in real-time intra-operatively allowing adjustments to be made. The impact of this adjustment on outcomes will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgeon blinded | Active Comparator | Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected. |
|
| Surgeon unblinded | Experimental | Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. The surgeon will be aware of force measurements in real-time, allowing for adjustments to reduce applied force during direct laryngoscopy. Post-operative outcome measures will be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct laryngoscopy force modulation | Procedure | Modification of applied force during direct laryngoscopy using real-time force sensor measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Form McGill Pain Questionnaire (SF-MPQ) | The SF-MPQ includes the following components: 15 descriptors:
A Present Pain Intensity (PPI) scale (0=No Pain, 1=Mild, 2=Discomforting, 3=Distressing, 4=Horrible, 5=Excruciating) Visual Analogue Scale of average pain (VAS, 0-10 cm) - higher score is worse pain | 1 day, 14 days, and 1 month post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Tongue mobility | Assessment of changes in tongue mobility post-operatively. My physician report Tongue deviation is: 0 - absent 1 - present | 1 month post-operatively |
| Tongue sensation | Assessment of changes in tongue sensation post-operatively, according to patient report: My tongue numbness is: 0 - absent
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riley Jackson | Contact | 6282526882 | riley.jackson@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tyler Crosby, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94115 | United States |
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| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Direct laryngoscopy without force modulation | Procedure | Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force |
|
| 1 day, 14 days, and 1 month post-operatively |
| Change in taste | Assessment of changes in taste post-operatively, according to patient report: My tongue numbness is: 0 - absent 1 - minimal 2 - mild 3 - moderatre 4 - severe | 1 day, 14 days, 1 month post-operatively |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |