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NCT Number: NCT05960539

Robotic Curriculum for Young Surgeons

Robotic training program for unexperienced novice surgeons

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Key information

Conditions

Robotic Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

Otto-von-Guericke University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location status: Recruiting

Location contact

Jessica Stockheim, MD

CONTACT

[email protected]

00493916715500

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • robotic procedures

Exclusion criteria

  • no consent of patients or surgeons

Treatment and study plan

surgical training

Procedure

surgical residency focussed on visceral robotic procedures

Primary outcomes

  1. perioperative morbidity

    Time frame: 5 years

    complications classified by Clavien-Dindo

  2. patient mortality rate

    Time frame: 5 years

    during in-hospital stay, 30 and 90 days postoperatively

  3. intraoperative workload

    Time frame: 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."

  4. basic robotic competence

    Time frame: 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 outcomes

  1. patient characteristics

    Time frame: 5 years

    age, sex, BMI, preexisting illnesses and diseases

  2. patient laboratory parameters

    Time frame: 5 years

    pre- and postoperatively: concentration of hemoglobin and tsh, crp value, estimated glomerular filtration rate, concentration of albumin, prothrombin time

  3. surgical expertise

    Time frame: 5 years

    analysis of experience for open, laparoscopic and robotic procedures by counting numbers of procedures and surgical practice in years

  4. practical resident training

    Time frame: 5 years

    percentage of intraoperative procedural steps performed by the assisting surgeon

  5. robotic bedside assistance

    Time frame: 5 years

    analysis of duration of port placement and docking in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Aristotelis Perrakis, Prof.

CONTACT

[email protected]

00493916715500

Jessica Stockheim, MD

CONTACT

[email protected]

00493916715500

Sponsors and collaborators

Lead sponsor

Otto-von-Guericke University Magdeburg

Other

Registry information

Acronym: RoCS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2023
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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