NCT06951360

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

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

Timeline
4mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Progress93%
May 2022Sep 2026

Study Start

First participant enrolled

May 15, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2022

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3.9 years

First QC Date

May 22, 2022

Last Update Submit

April 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overall workload

    NASA Task Load overall workload

    5 years

  • surgical expertise

    surgical experience counting numbers of open, laparoscopic, robotic procedures and years of surgical practice

    5 years

Secondary Outcomes (4)

  • NASA Task Load Index subscales

    5 years

  • procedure's difficulty level

    5 years

  • patient factors

    5 years

  • procedure characteristics

    5 years

Study Arms (2)

robotic procedures

residents, specialists and experts performing robotic visceral surgeries

Procedure: ENERGY questionnaire

laparoscopic procedures

residents, specialists and experts performing laparoscopic visceral surgeries

Procedure: ENERGY questionnaire

Interventions

Questionnaire including NASA Task Load Index, difficulty level of operation, patient and operation factors

laparoscopic proceduresrobotic procedures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • robotic and laparoscopic procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otto-von-Guericke University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Related Publications (2)

  • Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.

    PMID: 21330339BACKGROUND
  • Lowndes BR, Forsyth KL, Blocker RC, Dean PG, Truty MJ, Heller SF, Blackmon S, Hallbeck MS, Nelson H. NASA-TLX Assessment of Surgeon Workload Variation Across Specialties. Ann Surg. 2020 Apr;271(4):686-692. doi: 10.1097/SLA.0000000000003058.

    PMID: 30247331BACKGROUND

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

May 22, 2022

First Posted

April 30, 2025

Study Start

May 15, 2022

Primary Completion

April 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations