NCT02958826

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

November 2, 2016

Results QC Date

January 17, 2018

Last Update Submit

September 25, 2018

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

  • 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.

Study Arms (2)

No Smoke Evacuation

No Smoke Evacuation Group, anonymous questionnaire administered

Other: Questionnaire

Smoke Evacuation

Smoke Evacuation Group, anonymous questionnaire administered

Other: Questionnaire

Interventions

QuestionnaireOTHER

Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.

No Smoke EvacuationSmoke Evacuation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult (\> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck.

You may qualify if:

  • All adult (\> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Hope Gole
Organization
University of Missouri
golehk@health.missouri.edu
573-882-8030

Study Officials

  • Nicholas Golda, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director-University of Missouri Dermatology Clinics

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 8, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 15, 2019

Results First Posted

February 15, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)