Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery

March 1, 2025 updated by: Shing Wong, Prince of Wales Hospital, Sydney

Randomized Controlled Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery

The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Department of Surgery, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Robotic surgeon

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm sleeve
Randomised to wear arm sleeve on left or right
Device: Arm sleeve
Randomised to wear arm sleeve on left or right

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle fatigue
Time Frame: 2 hours after intervention
Hand grip strength (muscle fatigue)was assessed at the beginning and at the two-hour mark during the robotic console component of the surgical case, using the Camry Electronic Handgrip Dynamometer (CAMRY model: SCACAM-EH101). The non-sleeve-wearing forearm acted as a control. During testing, the surgeon sat upright with the elbows flexed at right angles by the side of the body and hands in neutral positions (halfway between supination and pronation). The handle was pulled with maximum force for three seconds. The hand grip strength (measured in kg force) was recorded ten times for the dominant (right) and non-dominant (left) hands alternately.
2 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Wales Hospital, Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 1, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/ETH02203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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