NCT03096769

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

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

February 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

March 21, 2017

Last Update Submit

March 20, 2018

Conditions

Musculoskeletal StrainErgonomics

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in measurement of console settings (in cm)

    Baseline, up to 1 year

  • Change in measurement of console head angle (in degrees)

    Baseline, up to 1 year

Study Arms (1)

Study Arm

OTHER
Other: Ergonomist

Interventions

ErgonomistOTHER

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.

Study Arm

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fellowship trained, specialty board certified gynecologic surgeon.
  • Robot used for hysterectomy until completion of vaginal cuff closure.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • John A Occhino

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 30, 2017

Study Start

February 2, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)