Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery (ENERGY)

April 26, 2025 updated by: Jessica Stockheim, Otto-von-Guericke University Magdeburg

ENERGY Study - Workload Evaluation (Via NASA Task Load Index) of Robotic Assisted and Laparoscopic Surgery

workload evaluation (via NASA Task Load Index) of robotic- assisted and laparoscopic surgery

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

evaluation of individual and overall workload during robotic visceral surgeries using NASA Task Load Index and one additional question referring to difficulty level of the operation in comparison with laparoscopic procedures

Study Type

Observational

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

  • Germany
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Otto-von-Guericke University Magdeburg

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • involved medical stuff (surgeons, OR nurses, further professions)
  • patients undergoing laparoscopic and robotic procedures fulfilling the inclusion criterias

Description

Inclusion Criteria:

  • robotic and laparoscopic procedures

Exclusion Criteria:

  • decline of participation (patients, medical stuff)
  • paparoscopic appendectomies, laparoscopic cholecystectomies

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
robotic procedures
residents, specialists and experts performing robotic visceral surgeries
Procedure: ENERGY questionnaire
Questionnaire including NASA Task Load Index, difficulty level of operation, patient and operation factors
laparoscopic procedures
residents, specialists and experts performing laparoscopic visceral surgeries
Procedure: ENERGY questionnaire
Questionnaire including NASA Task Load Index, difficulty level of operation, patient and operation factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall workload
Time Frame: 5 years
NASA Task Load overall workload
5 years
surgical expertise
Time Frame: 5 years
surgical experience counting numbers of open, laparoscopic, robotic procedures and years of surgical practice
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NASA Task Load Index subscales
Time Frame: 5 years
mental, physical, temporal demand, performance, effort, frustration
5 years
procedure's difficulty level
Time Frame: 5 years
additional question to evaluate the variation of difficulty of the performed procedure to expected level of difficulty; 3 levels
5 years
patient factors
Time Frame: 5 years
age, sex, BMI, preexisting illnesses/diseases using CCI (Charlson Comorbidity Index), previous operations, ASA
5 years
procedure characteristics
Time Frame: 5 years
indication, performed operation, intraoperative complications using Clavien-Dindo classification, operation duration, blood loss
5 years

Collaborators and Investigators

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

Sponsor

Otto-von-Guericke University Magdeburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 15, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENERGY study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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