Ergonomics in Robotic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Strain; Ergonomics
• Intervention / Treatment: Other: Ergonomist

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in measurement of console settings (in cm)	Comparison between surgeon- and ergonomist-derived console settings	Baseline, up to 1 year
Change in measurement of console head angle (in degrees)	Comparison between surgeon- and ergonomist-derived console settings	Baseline, up to 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John A Occhino, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16-009275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No