Robotic SurgeryRoCSNCT05960539
Robotic Curriculum for Young Surgeons
An observational study of Robotic Surgery, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
Trial summary
Robotic training program for unexperienced novice surgeons Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Robotic Surgery
- What is being tested?
- surgical training
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2020to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- robotic procedures
Who cannot join
- no consent of patients or surgeons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Otto-von-Guericke University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Jessica Stockheim, MD, 00493916715500, jessica.stockheim@med.ovgu.de
About this study
Robotic training program for unexperienced novice surgeons
Read the 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).
- Conditions
- Robotic Surgery
- Being tested
- surgical training
- Keywords
- robotic surgery, NASA Task Load Index, training, curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical trainingProcedure or surgery
surgical residency focussed on visceral robotic procedures
| Study group | Role | What they receive |
|---|---|---|
| robotic procedures | surgical residents and experts; differentiation due to organ systems Receives: Procedure: surgical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative morbidity
complications classified by Clavien-Dindo
Measured: 5 years
patient mortality rate
during in-hospital stay, 30 and 90 days postoperatively
Measured: 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."
Measured: 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
Measured: 5 years
Secondary outcomes (5)
patient characteristics
age, sex, BMI, preexisting illnesses and diseases
Measured: 5 years
patient laboratory parameters
pre- and postoperatively: concentration of hemoglobin and tsh, crp value, estimated glomerular filtration rate, concentration of albumin, prothrombin time
Measured: 5 years
surgical expertise
analysis of experience for open, laparoscopic and robotic procedures by counting numbers of procedures and surgical practice in years
Measured: 5 years
practical resident training
percentage of intraoperative procedural steps performed by the assisting surgeon
Measured: 5 years
robotic bedside assistance
analysis of duration of port placement and docking in minutes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 May 2020
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Stockheim, Otto-von-Guericke University Magdeburg
- Investigators
- Roland S. Croner, Prof., Study director, Otto-von-Guericke University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960539
- Sponsor's protocol ID
- 152/20
- Acronym
- RoCS
- Status last verified
- Apr 2025
- First submitted
- 20 Feb 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Curriculum for Young Surgeons
- ClinicalTrials.gov ID
- NCT05960539
- Acronym / sponsor ID
- RoCS / 152/20
- Conditions
- Robotic Surgery
- Keywords
- robotic surgery, NASA Task Load Index, training, curriculum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Otto-von-Guericke University MagdeburgUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic training program for unexperienced novice surgeons
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| robotic procedures | – | Procedure: surgical trainingsurgical residents and experts; differentiation due to organ systems |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- robotic procedures
Key exclusion criteria (1 listed)
- no consent of patients or surgeons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical trainingsurgical residency focussed on visceral robotic procedures | Procedure or surgery | robotic procedures |
Primary outcome
perioperative morbidity
Time frame: 5 years
complications classified by Clavien-Dindo
patient mortality rate
Time frame: 5 years
during in-hospital stay, 30 and 90 days postoperatively
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."
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
5 secondary outcomes
patient characteristics
Time frame: 5 years
patient laboratory parameters
Time frame: 5 years
surgical expertise
Time frame: 5 years
practical resident training
Time frame: 5 years
robotic bedside assistance
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland S. Croner, Prof. study director
Otto-von-Guericke University of Magdeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgery, run by Otto-von-Guericke University Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Stockheim, MD (00493916715500, jessica.stockheim@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative morbidity (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.