NCT05960539

Brief Summary

Robotic training program for unexperienced novice surgeons

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

February 20, 2022

Last Update Submit

April 26, 2025

Conditions

Robotic Surgery

Keywords

robotic surgeryNASA Task Load Indextrainingcurriculum

Outcome Measures

Primary Outcomes (4)

  • perioperative morbidity

    complications classified by Clavien-Dindo

    5 years

  • patient mortality rate

    during in-hospital stay, 30 and 90 days postoperatively

    5 years

  • intraoperative workload

    The questionnaire NASA Task Load Index consists of 6 quesions addressing the individual overall workload. The question of level of procedure's difficulty is used to analyse the overall workload additionally referring to "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: 30247331."

    5 years

  • basic robotic competence

    Evaluation of the intraoperative performance of residents and specialists by the robotic expert using O-SCORE referring to doi:10.1097/ACM.0b013e3182677805. PMID: 22914526

    5 years

Secondary Outcomes (5)

  • patient characteristics

    5 years

  • patient laboratory parameters

    5 years

  • surgical expertise

    5 years

  • practical resident training

    5 years

  • robotic bedside assistance

    5 years

Study Arms (1)

robotic procedures

surgical residents and experts; differentiation due to organ systems

Procedure: surgical training

Interventions

surgical trainingPROCEDURE

surgical residency focussed on visceral robotic procedures

robotic procedures

Eligibility Criteria

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

* every surgery for which patients gave their consent to participating in the study * every surgeon giving consent of collecting data via this study

You may qualify if:

  • robotic procedures

You may not qualify if:

  • no consent of patients or surgeons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otto-von-Guericke University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Study Officials

  • Roland S. Croner, Prof.

    Otto-von-Guericke University of Magdeburg

    STUDY DIRECTOR

Central Study Contacts

Jessica Stockheim, MD

CONTACT

00493916715500jessica.stockheim@med.ovgu.de

Aristotelis Perrakis, Prof.

CONTACT

00493916715500aristotelis.perrakis@med.ovgu.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 20, 2022

First Posted

July 25, 2023

Study Start

May 1, 2020

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations

DE(1)