Robotic Curriculum for Young Surgeons

Robotic Surgery Clinical Trial

— RoCS  

Official title:

Robotic Curriculum for Young Surgeons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960539
• Other study ID #: 152/20
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: July 2023
• Source: Otto-von-Guericke University Magdeburg
• Contact: Jessica Stockheim, MD
• Phone: 00493916715500
• Email: jessica.stockheim[@]med.ovgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Robotic training program for unexperienced novice surgeons

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• robotic procedures

Exclusion Criteria:

• no consent of patients or surgeons

Related Conditions & MeSH terms

• Robotic Surgery

Intervention

Procedure:
• surgical training
surgical residency focussed on visceral robotic procedures

Locations

Country	Name	City	State
Germany	Otto-von-Guericke University Magdeburg	Magdeburg	Saxony-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Otto-von-Guericke University Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative morbidity	complications classified by Clavien-Dindo	5 years
Primary	patient mortality rate	during in-hospital stay, 30 and 90 days postoperatively	5 years
Primary	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
Primary	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	patient characteristics	age, sex, BMI, preexisting illnesses and diseases	5 years
Secondary	patient laboratory parameters	pre- and postoperatively: concentration of hemoglobin and tsh, crp value, estimated glomerular filtration rate, concentration of albumin, prothrombin time	5 years
Secondary	surgical expertise	analysis of experience for open, laparoscopic and robotic procedures by counting numbers of procedures and surgical practice in years	5 years
Secondary	practical resident training	percentage of intraoperative procedural steps performed by the assisting surgeon	5 years
Secondary	robotic bedside assistance	analysis of duration of port placement and docking in minutes	5 years