Welcome to the IPEG/KARL STORZ/Nationwide Children’s Hospital Neonatal MIS Trainer Project
This international project involving 19 countries is the result of a collaboration developed by Dr. Karen Diefenbach between KARL STORZ, Nationwide Children’s Hospital and IPEG. We are so excited you are joining us as a research site or an interested IPEG member following our progress.
Introduction
The Neonatal MIS Trainers are models scaled to the chest and abdomen of neonates. Each trainer is designed to develop a specific MIS skill set used in pediatric minimally invasive surgery. While mastery of these core skills is essential in performing minimally invasive surgery in a neonate, proficiency of these skills does not assure the ability to perform correction of complex congenital anomalies. Additional preparation including understanding the procedure itself, patient selection, set up, collaboration with other disciplines including anesthesia and nursing, and an understanding of the differences between the MIS and open approach as well as the potential pitfalls of the surgery is necessary for success.
Description of Models
The abdominal models will focus on basic dexterity skills and suturing adapted to the scale model for a neonatal patient. The chest models will emphasize suturing skills needed for esophageal anastomosis and congenital diaphragmatic hernia (CDH) repair.
Description of the Research Initiative
The planned research project for which KARL STORZ designed these neonatal trainers and made available to Nationwide Children’s and IPEG for this Grant program involves 2 required projects over an initial 2 year period. An optional 3rd study is available after the first year of the study is completed. It is anticipated that this research collaborative group will develop other projects during and after this initial 2 year period to utilize the resources committed-trainers and international research sites and personnel. The IPEG Education Committee will be involved and available to facilitate consideration of these initiatives.
Primary Aims: 1)To incorporate the Neonatal MIS Trainers into training programs, 2) To obtain baseline performance data for all participants for the basic skills of each model, and 3)To track interval performance data to document improvement in these core skills.
Secondary Aims: 1) To show correlation with practice sessions and achievement of proficiency in MIS skills 2) to show that practice allows participants to reach proficiency faster and that regardless of which group participants are assigned, (early practice vs. late practice) all participants reach proficiency by 12 months 3)To attempt to correlate the improvement of skills performed with the scaled models to improvement in operating room performance.
Study 1: (Years 1 and 2)
This portion of the project involves collecting baseline and interval data on 7 tasks for all participants over the first 2 years. Initial baseline data will be collected and recorded on the data collection sheet for all participants on each of the 7 tasks (contained in the 5 drills). This data collection will be repeated at 6 month intervals for a total of 5 discrete data points (1 baseline and 4 6 month intervals). A sample timeline is included below. This study addresses the primary aims.
Study 2: (Year 1, concurrent with Study 1)
This portion of the project involves dividing the participants into two groups based on formal or informal skills instruction and training. The participants will be randomized to Group 1 or Group 2 through the REDCap database. All participants in Groups 1 and 2 will have initial baseline data collected and recorded on the data collection sheet for each of the 7 tasks. Once the baseline data has been collected, Group 1 participants will be given formal, proctored practice sessions each month between the baseline data collection session and the first interval data collection session at 6 months. This will result in 6 formal practice sessions. See sample timeline below. Group 2 participants will be given access to the trainers, videos, and instruction manual but will have no formal, proctored practice sessions for the first 6 months. At the first interval data collection session (6 months after the baseline data collection session), all participants in both groups will perform the 7 tasks and a data collection sheet will be completed for each participant.
For the second 6 months, Groups 1 and 2 will switch training methods. Group 1 will be given access to trainers, videos and instruction manual and will practice without formal, proctored sessions. Group 2 will be given formal, proctored practice sessions each month between the first interval data collection (6 months) session and the second interval data collection session at 12 months. This will result in 6 formal practice sessions.
This study addresses secondary aims 1) and 2)..
Study 3: (Years 2 and 3)-OPTIONAL
Once the participant is determined to be proficient in suturing in the trainers, evaluation of intra-operative performance in MIS cases will be solicited from attendings and intra-operative performance data for suturing will be measured between 12 and 18 months after baseline performance. Sites interested in participating in this portion of the project will be identified after the trainers are delivered and Study’s 1 and 2 get underway. This study will address secondary aim 3).
REDCap Database
REDCap is an application that enables investigators to design databases and maintain research data using the world wide web. The software is produced and maintained by the REDCap Consortium with support from Vanderbilt University and is widely used for clinical research at academic medical centers worldwide. The REDCap server hosting data for this project is maintained by The Research Institute at Nationwide Children’s Hospital. The study data can be accessed by authorized users using a compatible web browser by visiting the following URL:
https://redcap.nchri.org/redcap_v7.1.2/index.php?pid=1162
In the current project, REDCap will be used by the SC or SD to enter details regarding participants in the NMTP as well as performance data from the individual TS completed by participants.
