- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01137305
Soft Skills and Surgical Performance (SSPSP)
Do Soft Skills Predict Surgical Performance? Do Soft Skills Predict Surgical Performance? A Prospective Randomized Controlled Single Center Educational Trial Evaluating Predictors of Skill Acquisition in Virtual Reality Laparoscopy
Background and hypothesis:
Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an additional impact of soft skills on VR- performance. Thus to hypothesize soft skills predicting surgical performance in a VR- setting.
Method:
A prospective randomized controlled single center educational trial was carried out to evaluate the impact of structured VR- training and defined soft skills such as self- efficacy, stress- coping and motivation on VR- performance.
Study Overview
Detailed Description
Method:
Eligibility criteria were surgical residency not exceeding the first year of surgical training, a limited experience in MIS and informed consent to the study procedures including an anonymized publication of the study data. Limited experience in MIS was defined as camera navigation in laparoscopic cholecystectomies only.
Fifty residents were enrolled and prospectively randomized to either three months of structured VR- training or no training. Every participant underwent a basic VR- skills assessment and a serial assessment of defined soft skills including self- efficacy, stress- coping and motivation prior to randomization.
Basic VR- skills were measured within seven modules of the VR- simulator LapSim® (Surgical Science, Goteborg, Sweden) including "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting". Each module had to be performed in two levels of difficulty- medium and hard. Means of defined parameters of VR- performance were generated. Defined parameters of VR- performance comprised "time to complete task", "economy of instrument motion" and "tissue damage".
Serial assessment of defined soft skills comprised standardized psychological paper- pencil questionnaires regarding self efficacy (GSE), stress coping (SVF 78) and motivation (QCM).
Participants randomized to the intervention group had to pass sessions of 45 minutes each twice a week for three months. Participants randomized to the control group underwent no training at all.
Three months after randomization, VR- performance was assessed likewise. Outcome measurement of VR- performance defined results derived from the most complex module "diathermy- cutting" as endpoint.
The study was approved by the local ethics committee. Participation of the study was voluntary. Data were blinded to the investigators.
The data were descriptively analysed using SPSS® software version 16.0 (SSPS®, Chicago, Illinois, USA). Spearman regression analysis was performed to correlate means of virtual laparoscopic performance and the results derived from serial psychological testing. The differences between the randomized groups were assessed by means of the non- parametric Mann-Whitney- Test regarding all parameters, laparoscopic performance as well psychological scores. Relation of means was carried out using the two- independent t- Test. The level of statistical significance was set at p < 0.050 (two-tailed).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- surgical residency not exceeding the first year of surgical training
- limited experience in MIS (camera navigation in laparoscopic cholecystectomies only)
- informed consent to study procedures and publication of anonymized data
Exclusion Criteria:
- surgical residency exceeding the first year of surgical training
- experience in MIS exceeding camera navigation in laparoscopic cholecystectomies
- lack of informed consent
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VR- performance after training
Time Frame: Three months
|
Outcome measurement comprised defined parameters of VR- performance including "time to complete task", economy of instrument motion" and "tissue damage" within the most complex module "diathermy cutting" as primary endpoint.
|
Three months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Iyad Hassan, MD, Department of Visceral-, Thoracic- and Vascular Surgery, Philipps- University Marburg, Germany
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Katja Maschuw, MD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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