Ergonomics in Robotic Surgery

Ergonomics Clinical Trial

Official title:

Ergonomics in Robotic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096769
• Other study ID #: 16-009275
• Status: Completed
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 20, 2018
• Start date: February 2, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to answer if an ergonomist can configure a daVinci robot console to improve surgeon discomfort. Adjustments to the robot console will be surgeon specific as they are tailored to their individual body type. Measurements will be taken at the time of console configuration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Fellowship trained, specialty board certified gynecologic surgeon.

• Robot used for hysterectomy until completion of vaginal cuff closure.

Exclusion Criteria:

• Any non-robotic method to perform hysterectomy (laparotomy, non-robotic laparoscopic, vaginal approach).

Related Conditions & MeSH terms

• Ergonomics
• Musculoskeletal Strain

Intervention

Other:
• Ergonomist
The intervention consists of each surgeon meeting with an ergonomist where the ergonomist will adjust the console settings and chair height to an ergonomically optimal position.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Nordic Upper Body Questionnaire Score	The Nordic upper body questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.	Baseline, Immediately postoperative (approximately one hour)
Primary	Change in Body Part Discomfort Questionnaire Score	The Body Part Discomfort Questionnaire will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy	Baseline, Immediately postoperative (approximately one hour)
Primary	Surgical Task Load Index Score	The surgical task load index score will be one measure of upper body musculoskeletal discomfort following robotic hysterectomy.	Immediately postoperative (approximately one hour)
Secondary	Change in measurement of console settings (in cm)	Comparison between surgeon- and ergonomist-derived console settings	Baseline, up to 1 year
Secondary	Change in measurement of console head angle (in degrees)	Comparison between surgeon- and ergonomist-derived console settings	Baseline, up to 1 year