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The purpose of this study is to determine the effect surgical lights, surgical smoke, and surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.
The purpose of this study is to determine the impact of external sensory stimuli on patient preferences during outpatient Mohs surgery. Study participants will be asked to complete a questionnaire after their procedure sharing their experience with surgical lights, surgical smoke, and surgical noise. All responses are anonymous.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Smoke Evacuation | No Smoke Evacuation Group, anonymous questionnaire administered |
| |
| Smoke Evacuation | Smoke Evacuation Group, anonymous questionnaire administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Surgical Lights on Patient Preference | Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights. | Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year. |
| Effects of Surgical Smoke on Patient Preference | Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical smoke. | Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year. |
| Effect of Surgical Sounds on Patient Preference | Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical sounds. | Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year. |
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Inclusion Criteria:
Exclusion Criteria:
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All adult (> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck.
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Golda, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Smoke Evacuation Group | Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction). |
| FG001 | Control Group | Control group with sham smoke evacuation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Smoke Evacuation Group | Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction). |
| BG001 | Control Group | Control group with sham smoke evacuation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Two participants did not respond to this question |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Surgical Lights on Patient Preference | Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights. | Posted | Number | percentage of participants | Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year. |
|
Adverse data were collected on the day of surgery for the time required to complete the procedure and questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smoke Evacuation Group | Treatment group with smoke evacuation used during the entire procedure (Mohs and reconstruction). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hope Gole | University of Missouri | 573-882-8030 | golehk@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2016 | Sep 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 10 participants did not answer this question | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Smoke Evacuation Group, anonymous questionnaire administered Questionnaire: Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure. |
|
|
| Primary | Effects of Surgical Smoke on Patient Preference | Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical smoke. | Frequency of participants. | Posted | Number | percentage of participants | Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year. |
|
|
|
| Primary | Effect of Surgical Sounds on Patient Preference | Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical sounds. | Posted | Number | percentage of participants | Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year. |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Control Group | Control group with sham smoke evacuation. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Would Not be More Satisfied with Smoke Evacuation |
|
| Would not be more satisfied if sounds reduced |
|