Robotic Curriculum for Young Surgeons (RoCS)

Robotic training program for unexperienced novice surgeons

Study Overview

• Status: Recruiting
• Conditions: Robotic Surgery
• Intervention / Treatment: Procedure: surgical training

Detailed Description

The curricular structure of RoCS bases on five modules: multimodular didactics, standardization, training structure, interdisciplinary workplace and evaluation. The aim is to ensure a basic competence of robotic surgcial skills for unexperienced novice surgeons (residents).

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jessica Stockheim, MD; Phone Number: 00493916715500; Email: jessica.stockheim@med.ovgu.de
• Study Contact Backup: Name: Aristotelis Perrakis, Prof.; Phone Number: 00493916715500; Email: aristotelis.perrakis@med.ovgu.de

Study Locations

• Germany
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Recruiting
      • Otto-von-Guericke University Magdeburg
      • Contact: Jessica Stockheim, MD; Phone Number: 00493916715500; Email: jessica.stockheim@med.ovgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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

Description

Inclusion Criteria:

• robotic procedures

Exclusion Criteria:

• no consent of patients or surgeons

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
robotic procedures; surgical residents and experts; differentiation due to organ systems	Procedure: surgical training; surgical residency focussed on visceral robotic procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient characteristics	age, sex, BMI, preexisting illnesses and diseases	5 years
patient laboratory parameters	pre- and postoperatively: concentration of hemoglobin and tsh, crp value, estimated glomerular filtration rate, concentration of albumin, prothrombin time	5 years
surgical expertise	analysis of experience for open, laparoscopic and robotic procedures by counting numbers of procedures and surgical practice in years	5 years
practical resident training	percentage of intraoperative procedural steps performed by the assisting surgeon	5 years
robotic bedside assistance	analysis of duration of port placement and docking in minutes	5 years

Collaborators and Investigators

• Sponsor: Otto-von-Guericke University Magdeburg
• Investigators: Study Director: Roland S. Croner, Prof., Otto-von-Guericke University of Magdeburg

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

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

• Keywords: training; robotic surgery; NASA Task Load Index; curriculum
• Other Study ID Numbers: 152/20

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