RoCS: Robotic Curriculum for Young Surgeons

Sponsor

Otto-von-Guericke University Magdeburg (Other)

Overall Status

Recruiting

CT.gov ID

NCT05960539

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Robotic training program for unexperienced novice surgeons

Condition or Disease	Intervention/Treatment	Phase
Robotic Surgery	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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Robotic Curriculum for Young Surgeons

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

robotic procedures

surgical residents and experts; differentiation due to organ systems

Procedure: surgical training

surgical residency focussed on visceral robotic procedures

Outcome Measures

Primary Outcome Measures

perioperative morbidity [5 years]
complications classified by Clavien-Dindo
patient mortality rate [5 years]
during in-hospital stay, 30 and 90 days postoperatively
intraoperative workload [5 years]
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."
basic robotic competence [5 years]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

robotic procedures

Exclusion Criteria:

no consent of patients or surgeons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Otto-von-Guericke University Magdeburg	Magdeburg	Saxony-Anhalt	Germany	39120

Sponsors and Collaborators

Otto-von-Guericke University Magdeburg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jessica Stockheim, MD, Otto-von-Guericke University Magdeburg

ClinicalTrials.gov Identifier:

NCT05960539

Other Study ID Numbers:

152/20

First Posted:

Jul 25, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jessica Stockheim, MD, Otto-von-Guericke University Magdeburg

Study Results

No Results Posted as of Jul 25, 2023